Green Card Associate Director Clinical Quality Assurance Jobs
Associate Director Clinical Quality Assurance roles qualify for EB-2 or EB-3 green card sponsorship through PERM labor certification, which requires your employer to document that no equally qualified U.S. worker is available. Pharmaceutical, biotech, and medical device companies routinely sponsor this title because the regulatory expertise is difficult to source domestically.
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Date: Jul 31, 2026
Location:
Somerset, NJ, US
Company: Lupin
Lupin U.S. is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Somerset, New Jersey is home to one of eighteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin. Somerset, New Jersey is also the location for Lupin’s U.S. Sales Operations and Marketing divisions, as well as internal Product Development teams. Lupin has a significant generic pipeline and a growing Specialty Brand presence in the U.S. Our Inhalation Research and Development facility is located in Coral Springs, Florida focusing on generic and branded orally inhaled and nasal drug products. Key shared service functions are found at our beautiful harbor side location in Baltimore, Maryland. Adding to Lupin’s U.S. footprint is a robust team of Clinical Operations experts in Blue Bell, Pennsylvania and a high performing Specialty salesforce located across the country. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Join our U.S. team and become part of an organization that encourages professional development and innovation! We are looking for passionate and driven individuals who will help us to continue making medicine widely accessible to patients, and who strive to work by Lupin’s Core Values of Teamwork, Passion for Excellence, Entrepreneurial Spirit, Respect and Care, Integrity, and Customer Focus.
Role Summary
The QA Associate is responsible for the assurance of the manufacturing activities within the Lupin Somerset sites. This position is responsible for working in the warehouse, process rooms, and packaging lines and evaluates all activities meets the acceptance criteria.
Essential Duties and Responsibilities
- Sample, inspect incoming raw materials, components, in-process, intermediates, and finished products and submits samples to the QC laboratory for analysis.
- Inspect the manufacturing equipment/rooms and packaging lines/ equipment for cleanliness and approve them for use before the operation.
- Perform QA in-process checks (Beginning, Middle and End) for manufacturing/packaging operations and determine the results meets against pre-determined standards and batch record.
- Conduct AQL inspections on incoming materials and finished dosage forms against pre-determined Quality attributes.
- Collect and maintain QA Retain samples from all products manufactured. Assure that all retains are stored appropriately for accountability, annual inspection.
- Sample and proofread all pharmaceutical labeling for conformance to the standard. Issues approved labels to the packaging lines for use.
- Inform immediately any manufacturing/packaging issue to the QA supervisor.
- Assure all activities are following the batch records, departmental SOP’s, GMP, and DEA regulations.
- Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation/yields.
- Ensure the proper isolation of rejected or defective product/ material generated during the batch process and accountability in the batch record.
- Monitor facility and product environmental operating conditions.
- Provide necessary support to conduct root cause analysis for any incidents generated at the facility during all phases of the production and packaging process.
- Perform other QA duties as assigned.
Qualification and Experience
An Associate Degree or a Bachelor’s Degree in a scientific field is preferred.
Minimum 3+ years' experience in a Quality Assurance role in the pharmaceutical industry.
Knowledge of the pharmaceutical manufacturing and/or packaging process.
Communication skills: Excellent command of written and spoken English.
Attention to detail is paramount.
Desire to achieve a high quality of work and diligent about following Standard Operating Procedures.
Knowledge and understanding of cGMPs, keeping up to date with current industry issues and changing regulations.
SAP, Trackwise, LIMS or similar QMS system knowledge preferred.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran status, or any other classification as required by applicable law.
The anticipated annual base salary range for this position in New Jersey is $45,000 to $63,000, plus a discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, the type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally, work is performed in a manufacturing environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails.
LI-CC
LI-DNI
Competencies
Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility
Quality Assurance Associate
Date: Jul 31, 2026
Location:
Somerset, NJ, US
Company: Lupin
Lupin U.S. is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Somerset, New Jersey is home to one of eighteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin. Somerset, New Jersey is also the location for Lupin’s U.S. Sales Operations and Marketing divisions, as well as internal Product Development teams. Lupin has a significant generic pipeline and a growing Specialty Brand presence in the U.S. Our Inhalation Research and Development facility is located in Coral Springs, Florida focusing on generic and branded orally inhaled and nasal drug products. Key shared service functions are found at our beautiful harbor side location in Baltimore, Maryland. Adding to Lupin’s U.S. footprint is a robust team of Clinical Operations experts in Blue Bell, Pennsylvania and a high performing Specialty salesforce located across the country. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Join our U.S. team and become part of an organization that encourages professional development and innovation! We are looking for passionate and driven individuals who will help us to continue making medicine widely accessible to patients, and who strive to work by Lupin’s Core Values of Teamwork, Passion for Excellence, Entrepreneurial Spirit, Respect and Care, Integrity, and Customer Focus.
Role Summary
The QA Associate is responsible for the assurance of the manufacturing activities within the Lupin Somerset sites. This position is responsible for working in the warehouse, process rooms, and packaging lines and evaluates all activities meets the acceptance criteria.
Essential Duties and Responsibilities
- Sample, inspect incoming raw materials, components, in-process, intermediates, and finished products and submits samples to the QC laboratory for analysis.
- Inspect the manufacturing equipment/rooms and packaging lines/ equipment for cleanliness and approve them for use before the operation.
- Perform QA in-process checks (Beginning, Middle and End) for manufacturing/packaging operations and determine the results meets against pre-determined standards and batch record.
- Conduct AQL inspections on incoming materials and finished dosage forms against pre-determined Quality attributes.
- Collect and maintain QA Retain samples from all products manufactured. Assure that all retains are stored appropriately for accountability, annual inspection.
- Sample and proofread all pharmaceutical labeling for conformance to the standard. Issues approved labels to the packaging lines for use.
- Inform immediately any manufacturing/packaging issue to the QA supervisor.
- Assure all activities are following the batch records, departmental SOP’s, GMP, and DEA regulations.
- Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation/yields.
- Ensure the proper isolation of rejected or defective product/ material generated during the batch process and accountability in the batch record.
- Monitor facility and product environmental operating conditions.
- Provide necessary support to conduct root cause analysis for any incidents generated at the facility during all phases of the production and packaging process.
- Perform other QA duties as assigned.
Qualification and Experience
An Associate Degree or a Bachelor’s Degree in a scientific field is preferred.
Minimum 3+ years' experience in a Quality Assurance role in the pharmaceutical industry.
Knowledge of the pharmaceutical manufacturing and/or packaging process.
Communication skills: Excellent command of written and spoken English.
Attention to detail is paramount.
Desire to achieve a high quality of work and diligent about following Standard Operating Procedures.
Knowledge and understanding of cGMPs, keeping up to date with current industry issues and changing regulations.
SAP, Trackwise, LIMS or similar QMS system knowledge preferred.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran status, or any other classification as required by applicable law.
The anticipated annual base salary range for this position in New Jersey is $45,000 to $63,000, plus a discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, the type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally, work is performed in a manufacturing environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails.
LI-CC
LI-DNI
Competencies
Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility
See all 1,041+ Green Card Associate Director Clinical Quality Assurance Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Green Card Associate Director Clinical Quality Assurance Jobs.
Get Access To All JobsTips for Finding Green Card Sponsorship in Associate Director Clinical Quality Assurance
Translate your QA credentials for PERM
PERM requires your employer to define minimum qualifications that match your actual background. Document your specific regulatory frameworks, such as ICH Q10, FDA 21 CFR Part 11, or GMP audit experience, so the job description defensibly captures your credentials without overstating requirements.
Target companies with active PERM filing history
Biotech and pharmaceutical companies that have filed PERM for clinical quality roles before are far more likely to sponsor again. Search DOL PERM disclosure data by SOC code 11-9121 to identify employers who have certified similar positions in the last two years.
Verify prevailing wage tier before accepting an offer
Use the OFLC Wage Search to confirm which wage level your employer is targeting for your location. Associate Director roles typically fall at Level III or IV, and a Level II wage determination can trigger a DOL audit that delays your PERM certification by months.
Search green card sponsoring employers on Migrate Mate
Filter your job search by employers with documented EB-2 and EB-3 sponsorship history for clinical quality roles. Migrate Mate surfaces this data so you can prioritize companies already familiar with PERM requirements for Associate Director-level positions.
Negotiate the PERM filing timeline into your offer
Ask during the offer stage when your employer plans to begin PERM recruitment. Many companies delay filing for 12 to 18 months post-hire, which affects your priority date and overall green card timeline, especially if you are subject to per-country EB-2 backlogs.
Use your O*NET profile to strengthen the EB-2 case
The O*NET occupation profile for this role supports an advanced degree requirement, which is the foundation of an EB-2 petition. Confirm your employer's job description aligns with O*NET's defined knowledge and skill requirements before USCIS adjudicates your I-140.
Green Card Associate Director Clinical Quality Assurance: Frequently Asked Questions
Does Associate Director Clinical Quality Assurance qualify for EB-2 or EB-3 sponsorship?
Both categories are available depending on your credentials and your employer's job requirements. EB-2 applies when the position requires an advanced degree, which is common at the Associate Director level in clinical QA. EB-3 covers roles requiring a bachelor's degree plus progressive experience. Your employer's PERM job description determines which category applies, and USCIS adjudicates the I-140 petition accordingly.
How does PERM green card sponsorship differ from H-1B for this role?
H-1B visa authorization is temporary and subject to annual cap constraints, while PERM-based sponsorship leads to lawful permanent residency with no renewal requirement. The PERM process involves a DOL-supervised recruitment period and a certified labor condition before USCIS reviews your I-140. For most countries outside India and China, EB-3 priority dates are current or near-current, meaning the total timeline to a green card can be shorter than multiple H-1B renewal cycles.
What makes a clinical quality employer likely to sponsor a green card for this title?
Employers with established regulatory affairs or quality infrastructure, particularly those holding FDA-regulated product portfolios, are most likely to sponsor. Companies that have previously certified PERM applications for QA leadership roles have the internal legal and HR processes already in place. Reviewing DOL PERM disclosure data by job title and employer is one way to identify this history before you apply.
Where can I find Associate Director Clinical Quality Assurance jobs with green card sponsorship?
Migrate Mate specializes in employment-based green card job searches and lets you filter specifically for EB-2 and EB-3 sponsoring employers in clinical quality. Rather than sorting through general postings, you can target companies with verified sponsorship history for this title, which reduces the risk of investing in an application process that stalls at the PERM stage.
How long does the PERM process typically take for a clinical QA leadership role?
DOL PERM recruitment and audit periods vary, but most straightforward cases take between eight and fourteen months from the start of the supervised recruitment process to labor certification. If DOL issues an audit request, the timeline can extend significantly. After PERM certification, your employer files the I-140 with USCIS, and if your priority date is current, adjustment of status can proceed in parallel or shortly after.