dismissed H-1B Case: Pharmaceuticals

U.S. Citizenship 
and Immigration 
Services 
In Re: 9609558 
Appeal of Vermont Service Center Decision 
Form 1-129, Petition for a Nonimmigrant Worker (H-1B) 
Non-Precedent Decision of the 
Administrative Appeals Office 
Date: OCT. 23, 2020 
The Petitioner, a pharmaceutical packaging company, seeks to temporarily employ the Beneficiary as a 
"quality control systems manager" under the H-1B nonimmigrant classification for specialty 
occupations. Immigration and Nationality Act (the Act) section 101(a)(15)(H)(i)(b), 8 U.S.C. 
§ 1101(a)(15)(H)(i)(b). The H-1B program allows a U.S. employer to temporarily employ a qualified 
foreign worker in a position that requires both (a) the theoretical and practical application of a body 
of highly specialized knowledge and (b) the attainment of a bachelor's or higher degree in the specific 
specialty (or its equivalent) as a minimum prerequisite for entry into the position. 
The Director of the Vermont Service Center denied the petition, concluding that the record did not 
establish that the proffered position is a specialty occupation. The matter is now before us on appeal. 
The Petitioner bears the burden of proof to demonstrate el igibi I ity by a preponderance of the evidence. 
Section 291 of the Act; Matter of Chawathe, 25 l&N Dec. 369, 375 (AAO 2010). We review the 
questions in this matter de nova. See Matter of Christa's Inc., 26 l&N Dec. 537, 537 n.2 (AAO 2015). 
Upon de nova review, we will dismiss the appeal. 
I. LEGAL FRAMEWORK 
Section 101(a)(15)(H)(i)(b) of the Act defines an H-1B nonimmigrant as a foreign national "who is 
coming temporarily to the United States to perform services ... in a specialty occupation described in 
section 214(i)(l) ... " (emphasis added). Section 214(i)(I) of the Act, 8 U.S.C. § 1184(i)(I), defines the 
term "specialty occupation" as an occupation that requires "theoretical and practical application of a 
body of highly specialized knowledge, and attainment of a bachelor's or higher degree in the specific 
specialty (or its equivalent) as a minimum for entry into the occupation in the United States." The 
regulation at 8 C.F.R. § 214.2(h)(4)(ii) largely restates section 214(i)(I) of the Act but adds a 
non-exhaustive list of fields of endeavor. In addition, 8 C.F.R. § 214.2(h)(4)(iii)(A) provides that the 
proffered position must meet one of four criteria to qualify as a specialty occupation position.1 Lastly, 
1 8 C.F.R. § 214.2(h)(4)(iii)(A) must be read with the statutory and regulatory definitions of a specialty occupation under 
8 C.F.R. § 214.2(h)(4)(i)(A)(1) states that an H-1B classification may be granted to a foreign national 
who "will perform services in a specialty occupation ... " (emphasis added). 
Accordingly, to determine whether the Beneficiary will be employed in a specialty occupation, we 
look to the record to ascertain the services the Beneficiary will perform and whether such services 
require the theoretical and practical application of a body of highly specialized knowledge attained 
through at least a bachelor's degree or higher in a specific specialty or its equivalent. Without 
sufficient evidence regarding the duties the Beneficiary will perform, we are unable to determine whether 
the Beneficiary will be employed in an occupation that meets the statutory and regulatory definitions of 
a specialty occupation and a position that also satisfies at least one of the criteria at 8 C.F.R. 
§ 214.2(h)(4)(iii)(A). The services the Beneficiary will perform in the position determine: (1) the normal 
minimum educational requirement for entry into the particular position, which is the focus of criterion 
1; (2) industry positions which are parallel to the proffered position and thus appropriate for review 
for a common degree requirement, under the first alternate prong of criterion 2; (3) the level of 
complexity or uniqueness of the proffered position, which is the focus of the second alternate prong 
of criterion 2; (4) the factual justification for a petitioner normally requiring a degree or its equivalent, 
when that is an issue under criterion 3; and (5) the degree of specialization and complexity of the 
specific duties, which is the focus of criterion 4. 8 C.F.R. § 214.2(h)(4)(iii)(A). 
By regulation, the Director is charged with determining whether the petition involves a specialty 
occupation as defined in section 214(i)(1) of the Act. 8 C.F.R. § 214.2(h)(4)(i)(B)(2). The Director 
may request additional evidence in the course of making this determination. 8 C.F.R. § 103.2(b)(8). 
In addition, a petitioner must establish eligibility at the time of filing the petition and must continue to 
be eligible through adjudication. 8 C.F.R. § 103.2(b)(1). 
11. PROFFERED POSITION 
The Petitioner indicated that the Beneficiary will test and approve packaging operations along with 
maintaining compliance with law. It provided the following job duties for the position as part of its 
initial filing and on appeal: 
I Facilitate the implementation of processes identification and solutions to 
compliance issues and overall development of QA strategies 
I Develop and implement the facility Quality System for OTC drug products. 
I Creation and implementation of Standard Operating Procedures for Quality 
Assurance, Warehousing, Packaging and Shipping and Receiving. 
I Create and maintain employee training program. 
I Manage Vendor Qualification Program. 
I Interface with Regulatory Agencies, vendors and external clients on quality issues. 
I Manage FDA Adverse Drug Event Reporting, 
I Perform internal and external audits to ensure CGMP compliance. 
I Manage the creation, review and approval of product labeling. 
section 214(i)(1) of the Act and 8 C.F.R. § 214.2(h)(4)(ii). We construe the term "degree" to mean not just any 
baccalaureate or higher degree, but one in a specific specialty that is directly related to the proposed position. See Royal 
Siam Corp. v. Chertoff, 484 F.3d 139, 147 (1st Cir. 2007) (describing "a degree requirement in a specific specialty" as 
"one that relates directly to the duties and responsibilities of a particular position"). 
2 
I Maintain company drug listing status, 
I Coordinate as necessary all phases of compliance for packaging, labeling and 
shipping. 
I Manage the necessary activities to be compliant with deviations, complaints and 
CAPA program. 
I Manage Annual Product Reviews. 
I Assume other related responsibilities as necessary. 
In its response to the Service's first request for evidence (RFE), the Petitioner provided a revised 
position description document which included the above duties, albeit in a different order. The RFE 
description also added information under the "Manage Annual Product Reviews" duty and included 
additional duties as follows: 
I Manage Annual Product Reviews. 
1. Indicate the percentage of time devoted to each duty; 
2. State the education, experience, training, and special skills required to perform 
these duties; and 
o 2-5 years related experience in solid dosage form manufacturing / 
packaging environment. 
3. Explain how the educational requirements relate to the position. 
I Verify and sampling [sic] of incoming materials for correctness. 
I Approve, release, monitor and perform start-up, in-process, and completion 
verifications of packaging operations. 
I Conduct visual and measurement tests in packaging. 
I Collect, identify, and maintains retention samples as required. 
I Complete any necessary inspections, including documentation for defective 
materials. 
I Sample and inspect product during production to assure the identity, quality and 
correctness against approved specifications. 
I Review documentation in packaging batch records to assure compliance with GMP 
requirements. 
I Due to a degree in MPA - Healthcare has an experience and deep knowledge in -
Public Policy Administration, Budgeting and Finance, Organizational Theory, 
Human Resources Management, Quantitative Methods for Administrators and IT 
Management. 
o Focus on the suitable systems as well as defining them in written procedures 
(SOPS) and determine compliance with Government regulations and 
procedures accordingly. 
o Manage the task of assuring that other units in the organization prepare data 
in an appropriate way to allow the release and certification of the material 
to the intended customer. 
o Navigating organizational, human resource and budgetary challenges in 
order to improve programs and policies that drive quality, serve the 
company to great accuracy and efficiency as well as ensure public safety 
are essential for filling this role 
3 
According to the Petitioner's original support letter, the position requires a Master or Bachelor's 
degree in Public Administration or a related field.2 
Ill. ANALYSIS 
Upon review of the record in its totality and for the reasons set out below, we determine that the 
Petitioner has not demonstrated that the proffered position qualifies as a specialty occupation.3 
Specifically, the record does not (1) describe the substantive nature of the work to be performed with 
sufficient detail; and (2) does not establish that the job duties require an educational background, or 
its equivalent, commensurate with a specialty occupation. 
A. Substantive Nature of Work 
As a threshold matter, we conclude that the Petitioner provided inconsistent information regarding the 
job duties and minimum requirements for the proffered position, which calls into question the 
substantive nature of the work to be performed by the Beneficiary. As quoted above, the Petitioner 
initially provided a job description that consisted of 14 bullet points. 4 Separately, in response to the 
Service's RFE, the Petitioner provided a revised position description which consisted of eight 
additional bullets and several new sub-bullets. Inconsistencies in the initial and RFE position 
descriptions raise questions relating to the substantive nature of the position. 
For example, it appears that the following information may have served as a guide in drafting the 
document and was accidentally inserted under the "Manage Annual Product Reviews" bullet: 
1. Indicate the percentage of time devoted to each duty; 
2. State the education, experience, training, and special skills required to perform 
these duties; and 
o 2-5 years related experience in solid dosage form manufacturing / packaging 
environment. 
3. Explain how the educational requirements relate to the position. 
Of these three items, the Petitioner did not address the first item because the percentage of time devoted 
to individual duties is not listed in the record. Although such a breakdown of duties is not required, 
the absence of the percentages of time raises questions with regard to the order of importance or 
frequency of occurrence (e.g., regularly, periodically, or at irregular intervals) with which the 
Beneficiary wi 11 perform the stated duties. The record does not specify which tasks are major functions 
of the proffered position. 
2 As will be discussed, the record is inconsistent on the actual academic requirements necessary to perform the duties of 
the proposed position. 
3 The Petitioner submitted documentation to support the H-1B petition, including evidence regarding the proffered position 
and its business operations. While we may not discuss every document submitted, we have reviewed and considered each 
one. 
4 A job description for the "Quality Control Systems Manger" position appears in the Petitioner's support letter. An 
unsigned and undated document listing identical duties for a "QA Manager" position description was also included with 
the original submission and on appeal. The revised RFE position description document indicates it is for the "Quality 
Control Systems Manager" position. Thus, it appears "QA Manager" position is another title for the proffered position. 
4 
The second item discusses "education, experience, training, and special skills required to perform 
these duties." The sole sub-bullet indicates the position requires "2-5 years related experience in solid 
dose form manufacturing / packaging environment." Although this experience requirement is 
consistent across the initial and RFE position desriotion documents, it is inconsistent with the 
Petitioner's support letter and the opinion letter from 15 both of which do not 
require experience for the position. The third item from this insertion concerns "educational 
requirements" and appears to be addressed by the following bullet and sub-bullets found at the end of 
the updated position description document: 
I Due to a degree in MPA - Healthcare has an experience and deep knowledge in -
Public Policy Administration, Budgeting and Finance, Organizational Theory, 
Human Resources Management, Quantitative Methods for Administrators and IT 
Management. 
o Focus on the suitable systems as well as defining them in written procedures 
(SOPS) and determine compliance with Government regulations and 
procedures accordingly. 
o Manage the task of assuring that other units in the organization prepare data 
in an appropriate way to allow the release and certification of the material 
to the intended customer. 
o Navigating organizational, human resource and budgetary challenges in 
order to improve programs and policies that drive quality, serve the 
company to great accuracy and efficiency as well as ensure public safety 
are essential for filling this role. 
This bullet and its sub-bullets appear to discuss how the Beneficiary's "Master in Public 
Administration - Healthcare" degree qualifies her for the position. However, it appears that the 
Petitioner is conflating the Beneficiary's qualifications with the minimum requirements for the 
position.6 Alternatively, the Petitioner may be changing the position requirements and stating that 
such a healthcare related public administration degree, or its equivalent, is required. 
Thus, the revised position description submitted with the RFE includes previously unmentioned duties, 
an inconsistent experience requirement, and unclear, if not inconsistent, educational requirements for 
the position. No explanation is provided by the Petitioner to reconcile the inconsistencies in its 
educational and experience requirements or explain the addition of new duties and how they relate to 
the duties as originally described. The Petitioner must resolve these inconsistencies and ambiguities 
in the record with independent, objective evidence pointing to where the truth lies. Matter of Ho, 19 
l&N Dec. 582, 591-92 (BIA 1988). The inconsistencies in the Petitioner's minimum requirements 
and the job duties undermine the Petitioner's claims regarding the proffered position. Unresolved 
material inconsistencies may lead us to reevaluate the reliability and sufficiency of other evidence 
submitted in support of the requested immigration benefit. Id. Even if we disregard inconsistencies 
in the record, as we will discuss further the duties described do not illuminate the practical application 
5! !is the Dean and a Professor of Systems Engineering in the.__ __________ __. 
I !at the! I. 
6 Cf Matter of Michael Hertz Assocs., 19 l&N Dec. 558, 560 (Comm'r 1988) ("The facts of a beneficiary's background 
only come at issue after it is found that the position in which the petitioner intends to employ him falls within [a specialty 
occupation]."). 
5 
of knowledge involved or any particular educational requirement associated with such duties. It is not 
possible to ascertain the nature and level of responsibility of the proposed position, including whether 
the duties as generally described correspond to the occupation designated on the labor condition 
application (LCA). We are therefore precluded from finding that the proffered position qualifies as a 
specialty occupation under any criterion at 8 C.F.R. § 214.2(h)(4)(iii)(A). Nevertheless, to be 
thorough we will analyze the proffered duties and the evidence of record to determine whether the 
proffered position as described would qualify as a specialty occupation. 
B. Specialty Occupation 
To determine whether a particular job qualifies as a specialty occupation, U.S. Citizenship and 
Immigration Services (USCIS) does not simply rely on a position's title. The specific duties of the 
proffered position, combined with the nature of the petitioning entity's business operations, are factors 
to be considered. USCIS must examine the ultimate employment of the alien and determine whether 
the position qualifies as a specialty occupation. See generally Defensor v. Meissner, 201 F. 3d 384. 
The critical element is not the title of the position nor an employer's self-imposed standards, but 
whether the position actually requires the theoretical and practical application of a body of highly 
specialized knowledge, and the attainment of a baccalaureate or higher degree in the specific specialty 
as the minimum for entry into the occupation, as required by the Act. To that end, we turn to the 
criteria at 8 C.F.R. § 214.2(h)(4)(iii)(A). 
1. First Criterion 
We turn first to the criterion at 8 C.F.R. § 214.2(h)(4)(iii)(A)(1), which requires that a baccalaureate 
or higher degree in a specific specialty, or its equivalent, is normally the minimum requirement for 
entry into the particular position. To inform this inquiry, we will consider the information contained 
in the U.S. Department of Labor's (DOL) Occupational Outlook Handbook (Handbook) regarding the 
duties and educational requirements of the wide variety of occupations it addresses. 7 
On the LCAsubmitted in support of the H-1B petition, the Petitioner designated the proffered position 
under the occupational category "Industrial Production Managers" corresponding to the Standard 
Occupational Classification code 11-3051. 8 The Handbook subchapter entitled "How to Become an 
Industrial Production Manager" states, in pertinent part: "[e]mployers prefer managers have at least a 
bachelor's degree. While the degree may be in any field, many industrial production managers have 
a bachelor's degree in business administration or industrial engineering."9 The Handbook also states: 
7 We do not maintain that the Handbook is the exclusive source of relevant information. That is, the occupational category 
designated by the Petitioner is considered as an aspect in establishing the general tasks and responsibilities of a proffered 
position, and we regularly review the Handbook on the duties and educational requirements of the wide variety of 
occupations that it addresses. Nevertheless, to satisfy the first criterion, the burden of proof remains on the Petitioner to 
submit sufficient evidence to support a finding that its particular position would normally have a minimum, specialty 
degree requirement, or its equivalent, for entry. 
8 A petitioner submits the LCA to DOL to demonstrate that it will pay an H-1B worker the higher of either the prevailing 
wage for the occupational classification in the area of employment or the actual wage paid by the employer to other 
employees with similar duties, experience, and qualifications. Section 212(n)(1) of the Act; 
20 C.F.R. § 655.731(a). 
9 Bureau of Labor Statistics, U.S. Dep't of Labor, Occupational Outlook Handbook, Industrial Production Managers, 
https://www.bls.gov/OOH/management/industrial-production-managers.htm#tab-4 (last visited Oct. 21, 2020). 
6 
"[s]ome begin working as an industrial production manager directly after college or graduate school. 
They may spend their first few months in training programs, becoming familiar with the production 
process, company policies, and safety regulations ... " and "[s]ometimes, production workers with 
many years of experience take management classes and become a production manager. At large 
plants, where managers have more oversight responsibilities, employers may look for managers who 
have a Master of Business Administration (MBA) or a graduate degree in industrial 
management."10 Thus, the Handbook does not support the assertion that a baccalaureate or higher 
degree in a specific specialty, or its equivalent, is normally the minimum requirement for entry into 
the occupation. The Handbook reports that a variety of paths are available to enter this occupation, 
including less than a bachelor's degree, 11 a general business administration bachelor's degree, 12 and 
degrees that may be in any field. Upon review, the Handbook does not support the assertion that the 
proffered position falls under an occupational category for which at least a bachelor's degree in a 
specific specialty, or its equivalent, is normally the minimum requirement for entry. 
We note too that the Petitioner cites to Tap is I nt'I v. I NS, 94 F. Supp. 2d 172 (D. Mass. 2000) and, 
among other cases, Residential Finance Corp. v. USCIS, 839 F. Supp. 2d 985 (S.D. Ohio 2012) to 
support its claim that the first regulatory criterion does not preclude a finding of a specialty occupation 
position when multiple disciplines may be permitted. We agree that "[t]he knowledge and not the title 
of the degree is what is important."13 In general, provided the specialties are closely related, e.g., 
chemistry and biochemistry, a minimum of a bachelor's or higher degree in more than one specialty 
is recognized as satisfying the "degree in the specific specialty (or its equivalent)" requirement of 
section 214(i)(1)(B) of the Act. In such a case, the required "body of highly specialized knowledge" 
would essentially be the same. Since there must be a close correlation between the required "body of 
highly specialized knowledge" and the position, however, a minimum entry requirement of a degree 
in two disparate fields, such as philosophy and engineering, would not meet the statutory requirement 
that the degree be "in the specific specialty (or its equivalent)," unless the Petitioner establishes how 
each field is directly related to the duties and responsibilities of the particular position. Section 
214(i)(1)(B) of the Act (emphasis added). In this matter, as discussed the Handbook does not establish 
a requirement for a "bachelor's or higher degree in a particular specialty." Thus, the Petitioner's 
reliance on the Handbook to establish that this occupation requires a bachelor's or higher degree in a 
specific specialty, or its equivalent, is not well-founded. 
In any event, the Petitioner has not furnished evidence to establish that the facts of the instant petition 
are analogous to those in Residential Finance and Tapis, both of which concerned marketing-related, 
not quality control systems or industrial production management-related, occupations. We also note 
that, in contrast to the broad precedential authority of the case law of a U.S. circuit court, we are not 
bound to follow the published decision of a U.S. district court in matters arising even within the same 
10 Id. 
11 The Handbook states that employers may prefer managers who have at least a bachelor's degree; however, 
a preference for a degree is not necessarily an indication of a minimum requirement. The Handbook also reports that some 
individuals with many years of experience and a few management courses may qualify to perform this occupation. 
12 A bachelor's degree in business administration is inadequate to establish that a position qualifies as a specialty 
occupation. We have consistently stated that, although a general-purpose bachelor's degree, such as a degree in business 
administration, may be a legitimate prerequisite for a particular position, requiring such a degree, without more, will not 
justify a conclusion that a particular position qualifies for classification as a specialty occupation. Royal Siam Corp., 484 
F.3d at 147. 
13 Residential Finance, 839 F. Supp. 2d at 997 (citing Tapis, 94 F. Supp. 2d at 175-76). 
7 
district. See Matter of K-S-, 20 l&N Dec. 715, 719-20 (BIA 1993). Although the reasoning underlying 
a district judge's decision will be given due consideration when it is properly before us, the analysis 
does not have to be followed as a matter of law. Id. 
Further, as noted, the record contains inconsistent requirements for the proffered position. Thus, in 
the instant matter, the Petitioner has not provided documentation from a probative source to 
substantiate its assertion regarding the normal minimum requirement for entry into this particular 
position. Thus, the Petitioner has not satisfied the criterion at 8 C.F.R. § 214.2(h)(4)(iii)(A)(1). 
2. Second Criterion 
The second criterion presents two, alternative prongs: "The degree requirement is common to the 
industry in parallel positions among similar organizations or, in the alternative, an employer may show 
that its particular position is so complex or unique that it can be performed only by an individual with 
a degree[.]" 8 C.F.R. § 214.2(h)(4)(iii)(A)(2) (emphasis added). The first prong contemplates 
common industry practice, while the alternative prong narrows its focus to the Petitioner's specific 
position.14 
To satisfy this first prong of the second criterion, the Petitioner must establish that the "degree 
requirement" (i.e., a requirement of a bachelor's or higher degree in a specific specialty, or its 
equivalent) is common to the industry in parallel positions among similar organizations. We generally 
consider the following sources to determine if there is such a common degree requirement: whether 
the Handbook reports that the industry requires a degree; whether the industry's professional 
association has made a degree a minimum entry requirement; and whether letters or affidavits from 
firms or individuals in the industry establish that such firms "routinely employ and recruit only degreed 
individuals." See Shanti, Inc. v. Reno, 36 F. Supp. 2d 1151, 1165 (D. Minn. 1999) (quoting 
Hird/Blaker Corp. v. Sava, 712 F. Supp. 1095, 1102 (S.D.N.Y. 1989) (considering these "factors" to 
inform the commonality of a degree requirement)). 
As discussed above, the Handbook does not indicate that a bachelor's degree in a specific specialty is 
a common requirement within the industry. Also, contrary to its assertions about the significance of 
previously submitted evidence, the Petitioner did not submit evidence from an industry professional 
association or from firms or individuals in the industry that show such a degree is a minimum 
requirement for entry into the position. Relevant to this prong, the Petitioner submitted four job 
announcements for positions it claims are parallel to the proffered position, the opinion letter from 
I I and a position description from Health Pharma USA, LLC (Health Pharma). The 
job announcements do not indicate the relative size of the organizations. Also, although the 
organizations appear to generally serve the pharmaceutical and healthcare sectors, there is insufficient 
information in the record to determine the extent to which their products and services overlap with 
those of the Petitioner or the comparative nature of their operations. Additionally, the advertised 
positions do not appear parallel to the proffered position as all require relevant experience, and the 
experience requirements are markedly different than those of the Petitioner. Where the Petitioner may 
accept either two years of experience and a general degree (per the position description documents) or 
no experience and a Public Administration degree or the equivalent (per its support letter), all the job 
14 The second prong of the second criterion will be discussed below. 
8 
announcements require or prefer five or more years of relevant experience. Thus, the advertised 
positions appear to be for more senior positions than the position proffered here. Further, even if the 
positions and organizations were found to be parallel and similar, three of the job announcements do 
not indicate they require a degree in a specific specialty or its equivalent. The educational 
requirements range from any "B.S. or B.A. degree in a scientific discipline" to any "Bachelor's 
degree" to no degree. Thus, the advertisements, at most, confirm the Handbook's report that there is 
a wide variety of methods to enter into this occupation. 
Next, the Petitioner challenges the Director's analysis of~----~s opinion. We note here 
thatl • s opinion, submitted at the same time as the updated position description 
document, references only the duties as initially described by the Petitioner and the professor appears 
unaware of the seven new duties and experience requirements. The professor's apparent lack of 
awareness of the revised duties of the proffered position raises questions regarding their knowledge of 
the Petitioner's business operations and its requirements for the proffered position. Moreover, 
I ldoes not discuss any relevant research, studies, or authoritative industry publications 
utilized as part of the review and foundation for the opinion that quality assurance manager positions 
require a bachelor's degree in a specific specialty, or its equivalent, to perform duties such as those 
described. We may, in our discretion, use opinion statements submitted by the Petitioner as advisory. 
Matter of Caron lnt'I, Inc., 19 l&N Dec. 791, 795 (Comm'r 1988). However, where an opinion is not 
in accord with other information or is in any way questionable, we are not required to accept or may 
give less weight to that evidence. Id. 
Finally, the Director found that the Health Pharma letter does not discuss the position requirements 
for Quality Assurance Managers or otherwise establish that a bachelor's degree is a requirement for 
parallel positions in the Petitioner's industry. We agree and the Petitioner has not offered evidence on 
appeal challenging the Director's conclusion. 
On appeal, the Petitioner submitted no new evidence or arguments relevant to this prong not previously 
addressed adequately by the Director. Thus, the Petitioner has not satisfied the first alternative prong 
of 8 C.F.R. § 214.2(h)(4)(iii){A)(2). 
3. Third Criterion 
The third criterion of 8 C.F.R. § 214.2(h)(4)(iii)(A) entails an employer demonstrating that it normally 
requires a bachelor's degree in a specific specialty, or its equivalent, for the position. As noted by the 
Director, the Petitioner stated that it hasn't employed people in this position previously. While a 
first-time hiring for a position is certainly not a basis for precluding a position from recognition as a 
specialty occupation, it is unclear how an employer that has not previously recruited and hired for the 
position would be able to satisfy the criterion at 8 C.F.R. § 214.2(h)(4)(iii){A)(3). We observe the 
Petitioner does not challenge the Director's finding nor otherwise address eligibility under this 
criterion on appeal. The Petitioner has not satisfied the criterion at 8 C.F.R. § 214.2(h)(4)(iii){A)(3). 
4. Second Prong of the Second Criterion and the Fourth Criterion 
As noted above, the second alternative prong of 8 C.F.R. § 214.2(h)(4)(iii){A)(2), is satisfied if the 
Petitioner shows that its particular position is so complex or unique that it can be performed only by 
9 
an individual with at least a bachelor's degree in a specific specialty, or its equivalent. The fourth 
criterion at 8 C.F.R. § 214.2(h)(4)(iii)(A) requires a petitioner to establish that the nature of the specific 
duties is so specialized and complex that the knowledge required to perform them is usually associated 
with the attainment of a baccalaureate or higher degree in a specific specialty, or its equivalent. 
On appeal, the Petitioner argues "the Service Director overlooked the complex and unique aspect of 
the responsibilities conferred upon the Beneficiary as mentioned in the form of a letter of opinion 
provided from Health Pharma" that was included with its RFE response. However, as discussed by 
the Director, the letter from Health Pharma provided only a brief summary of its own Quality 
Assurance Manager position and a duty list without further explanation of industry standards or an 
analysis of why the Petitioner's proposed position is specialized and complex or unique. The Health 
Pharma letter did not label itself as an opinion, discuss industry standards, or even mention the 
Petitioner's company let alone its Quality Control Systems Manager position. Rather, the letter is a 
description of duties for a position within Health Pharma itself occupied by one of its employees. The 
letter does not discuss or offer an analysis of what makes its positions, or others similar to it, 
specialized and complex, or unique. As discussed above, although the Petitioner submitted an opinion 
letter purporting to be from an industry expert, we decline to afford that opinion significant weight. 
The Petitioner did not address on appeal other previously submitted evidence in the record relating to 
the specialized and complex or unique nature of its proffered position. Accordingly, we note here that 
we agree with the Director's findings that the Petitioner's job duties, as described, do not appear to be 
specialized and complex or unique as to require the attainment of a bachelor's degree in a specific 
specialty, or the equivalent. For example, duties such as "[m]anage the creation, review and approval 
of product labeling," "[c]onduct visual and measurement tests in packaging," and "[c]oordinate as 
necessary all phases of compliance for packaging, labeling and shipping" do not establish complexity 
or uniqueness. The Petitioner did not establish that only an individual with a degree in a specific 
specialty, or its equivalent could perform such duties. Further, the Petitioner does not explain or offer 
probative evidence demonstrating that a public administration degree or background is required to 
obtain the knowledge to "[m]anage FDA Adverse Drug Event Reporting," "[m]aintain company drug 
listing status," and inspect documentation for defective materials and product to assure identify, 
quality, and correctness. The Petitioner does not sufficiently distinguish its proffered position from 
those of other "Industrial Production Managers" who do not require a bachelor's degree in a specific 
specialty, or the equivalent. 
The Petitioner claims that the Beneficiary is well-qualified for the position and references her 
qualifications in the updated duty list it submitted and elsewhere in the record. However, the test to 
establish a position as a specialty occupation is not the education or experience of a particular 
beneficiary, but whether the position itself requires at least a bachelor's degree in a specific specialty, 
or its equivalent. The Petitioner did not sufficiently develop relative specialization and complexity or 
uniqueness as an aspect of the duties of the position, and again it did not identify any tasks that are so 
specialized and complex or unique that only a specifically degreed individual could perform them. 
Thus, the Petitioner has not demonstrated in the record that its proffered position is one with duties 
sufficiently specialized and complex or to satisfy the second prong of the criterion at 8 C.F.R. 
§ 214.2(h)(4)(iii)(A)(2) or the criterion at 8 C.F.R. § 214.2(h)(4)(iii)(A)(4). 
10 
Upon review of the totality of the evidence submitted, the Petitioner has not established that more 
likely than not, the proffered position is a specialty occupation under any of the criteria at 8 C.F.R. 
§ 214.2(h)(4)(iii)(A). Moreover, the record does not establish that the Petitioner satisfied the statutory 
and regulatory definitions of specialty occupation. 
IV. CONCLUSION 
In visa petition proceedings, it is the petitioner's burden to establish eligibility for the immigration 
benefit sought. Section 291 of the Act, 8 U.S.C. § 1361. The Petitioner has not met that burden. 
ORDER: The appeal is dismissed. 
11