OPT Quality Assurance Auditor Jobs
Quality Assurance Auditor roles are a strong fit for F-1 OPT students with degrees in engineering, computer science, or a related technical field. Most positions qualify as specialty occupations, making them straightforward for OPT authorization. STEM OPT extension eligibility is common, giving you up to three years of total work authorization.
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You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
- engage in work that matters to our customers and the patients they serve
- learn new skills and enjoy new experiences in an engaging and safe environment
- strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
QA Auditor I supports the Quality Assurance department by performing routine internal audits, reviewing quality systems, and assisting with compliance activities to ensure adherence to GMP, regulatory requirements, and company policies.
Responsibilities
- In Process/Finished Goods (FG) Analytical Record (AR) and Batch Record (BR) - Review
- SAP transactions
- Out Of Specification, Deviation, Investigation support and review utilizing TrackWise
- CAPA initiation and review
- Raw Material (RM) Analytical Record - Review & Approval
- Operations Notebook Issuance
- Participate in quarterly internal cGMP audits
- Rotational coverage as an after hour QA resource
- Issuance & Approval Inspect and approve repackaging records
All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
Qualifications/Skills
- Strong oral and written communication skills
- Proficient in windows based environment including word processing, spreadsheet and database programs
Education, Experience & Licensing Requirements
- BS in Chemistry or a related field or equivalent industry relevant experience. Classes or education in Chemistry, Mathematics, Engineering, and computer software beneficial
- 3 or more years of experience in manufacturing environment, preferably pharmaceuticals
- Working knowledge of current good manufacturing practices and ICH Q7 and 21 CFR part 210 and 211 will be highly beneficial and preferred
Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
Company Information
You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
- engage in work that matters to our customers and the patients they serve
- learn new skills and enjoy new experiences in an engaging and safe environment
- strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
QA Auditor I supports the Quality Assurance department by performing routine internal audits, reviewing quality systems, and assisting with compliance activities to ensure adherence to GMP, regulatory requirements, and company policies.
Responsibilities
- In Process/Finished Goods (FG) Analytical Record (AR) and Batch Record (BR) - Review
- SAP transactions
- Out Of Specification, Deviation, Investigation support and review utilizing TrackWise
- CAPA initiation and review
- Raw Material (RM) Analytical Record - Review & Approval
- Operations Notebook Issuance
- Participate in quarterly internal cGMP audits
- Rotational coverage as an after hour QA resource
- Issuance & Approval Inspect and approve repackaging records
All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
Qualifications/Skills
- Strong oral and written communication skills
- Proficient in windows based environment including word processing, spreadsheet and database programs
Education, Experience & Licensing Requirements
- BS in Chemistry or a related field or equivalent industry relevant experience. Classes or education in Chemistry, Mathematics, Engineering, and computer software beneficial
- 3 or more years of experience in manufacturing environment, preferably pharmaceuticals
- Working knowledge of current good manufacturing practices and ICH Q7 and 21 CFR part 210 and 211 will be highly beneficial and preferred
Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
See all OPT Quality Assurance Auditor Jobs
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Get Access To All JobsTips for Finding OPT Sponsorship as a Quality Assurance Auditor
Confirm your degree aligns with the role
QA Auditor positions require a field-specific degree to qualify as a specialty occupation. Engineering, computer science, information systems, or quality management degrees map most cleanly. A mismatch between your major and the job description can complicate OPT authorization.
Target employers with established QA teams
Companies with dedicated quality assurance departments are far more familiar with OPT work authorization than startups hiring their first QA hire. Manufacturing, medical device, aerospace, and software firms typically have HR processes already in place for international candidates.
Verify the role qualifies for STEM OPT extension
QA Auditor roles tied to engineering, computer science, or information technology SOC codes often qualify for the 24-month STEM OPT extension. Confirm your degree is on the STEM Designated Degree Program List before applying, since this significantly extends your authorization window.
Address OPT proactively in your application
Many employers filter out candidates who seem unclear about their work authorization. State your OPT status and end date confidently in cover letters. Emphasize that no visa petition is required from them during your OPT period, which removes the biggest hiring barrier upfront.
Pursue roles with compliance or regulatory focus
QA Auditor positions in regulated industries like pharmaceuticals, medical devices, and aerospace are more likely to sponsor H-1B visas after OPT. These employers already navigate complex regulatory environments, so they're more comfortable with immigration paperwork than general technology or retail companies.
Get your EAD card in hand before your start date
You cannot begin work as a QA Auditor until your EAD card physically arrives, even if USCIS has approved your OPT application. Apply at least 90 days before your program end date to avoid gaps between graduation and your employment start date.
Quality Assurance Auditor OPT: Frequently Asked Questions
Can F-1 OPT students work as Quality Assurance Auditors?
Yes. Quality Assurance Auditor roles typically qualify as specialty occupations because they require at least a bachelor's degree in a specific technical field such as engineering, computer science, or quality management. As long as your degree aligns with the position's requirements and your EAD card is active, you're authorized to work in this role during your OPT period.
Do Quality Assurance Auditor jobs qualify for the STEM OPT extension?
Many do, but it depends on the SOC code your employer uses for the position and whether your degree appears on the STEM Designated Degree Program List. QA roles tied to engineering, information technology, or computer science SOC codes commonly qualify. Confirm the SOC code with your employer and check with your DSO before assuming eligibility. The extension adds 24 months to your standard 12-month OPT period.
Which industries hire OPT students for Quality Assurance Auditor roles?
Pharmaceuticals, medical devices, aerospace, automotive, software, and electronics manufacturing are the most active industries for this role. Regulated industries tend to have formal QA departments and established processes for hiring international candidates. Browse open Quality Assurance Auditor positions on Migrate Mate, which filters specifically for employers open to OPT and visa sponsorship candidates.
What does OPT reporting look like for Quality Assurance Auditor positions?
You must report your employment to your DSO within 10 days of starting work. Required details include your employer's name, address, and the start date of your position. During STEM OPT, your employer must also enroll in E-Verify, provide a formal training plan using Form I-983, and conduct evaluations at the 12-month and 24-month marks. Missing these reporting deadlines can jeopardize your immigration status.
Are Quality Assurance Auditor employers likely to sponsor H-1B visas after OPT?
Employers in regulated industries such as pharmaceuticals, aerospace, and medical devices sponsor H-1B visas for QA roles at higher rates than most sectors. These companies are accustomed to compliance-heavy processes, and quality assurance functions are difficult to offshore, which increases sponsorship willingness. Targeting employers in these sectors during your OPT search gives you the best chance of a long-term immigration pathway.