Senior Quality Assurance Specialist, IVD
Bridgewater, NJContractSeen todaySeen in employer's feed today
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Requirements
Credentials this posting asks for.
Job overview
Insight Global is seeking a Senior Quality Assurance Specialist to support a rare disease biopharmaceutical company preparing for a potential launch of a product combining a small-molecule drug with an in vitro diagnostic. The consultant will adapt the existing Quality Management System for IVD requirements and assist with supplier qualification, CMO onboarding, quality documentation, and product disposition. About 70% to 75% of the role focuses on the IVD Quality Management System.
Skills & qualifications
Skills
Qualifications
Full job description
Job Description
Insight Global is seeking a Senior Quality Assurance Specialist to support a rare disease biopharmaceutical company preparing for the potential launch of a new product that combines a small-molecule drug with an in vitro diagnostic. This consultant will help adapt the company’s existing Quality Management System to support IVD-specific requirements. The role will also assist with supplier qualification, CMO onboarding, quality documentation, and product disposition activities. Approximately 70% to 75% of the role will focus on developing and improving the IVD Quality Management System, while approximately 25% will focus on onboarding and qualifying external manufacturing partners.
Skills and Requirements
Must-Have Requirements
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Bachelor’s degree in Biology, Chemistry, Microbiology, Biomedical Science, Engineering, Medical Technology, or a related scientific field
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At least three years of Quality Assurance, Quality Systems, or manufacturing quality experience in a regulated life sciences environment
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Direct experience developing, updating, or managing Quality Management Systems for in vitro diagnostics
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Strong knowledge of ISO 13485 and FDA medical-device Quality System requirements, including 21 CFR Part 820 or QMSR
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Experience reviewing deviations, investigations, CAPAs, change controls, and controlled quality documents
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Experience with supplier qualification, supplier quality audits, or CMO onboarding
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Experience with batch or lot record review, product disposition, or QA release activities
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Experience working with an electronic Quality Management System
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Ability to independently evaluate product risk, compliance impact, and quality documentation Nice-to-Have Skills
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Experience supporting combination products involving a pharmaceutical product and an IVD
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Working knowledge of ISO 14971 risk-management principles
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Experience supporting FDA, notified-body, supplier, or internal inspections
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ASQ Certified Quality Auditor, Certified Quality Engineer, or a similar quality certification
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Experience supporting new product introduction, technology transfer, or product launch readiness
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Familiarity with Microsoft Copilot or other AI-enabled productivity tools
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].
How this job compares
Set against the 4,809 open Quality Assurance jobs on Olive Jobs, counted November 11, 2026.
- Pay
- This postingNot listed
- New Jersey median$102–159K/yr83 salary ranges
- New Jersey median$26–29/hr27 hourly ranges
- Openings
- Olive Jobs lists 134 open Quality Assurance jobs in New Jersey and 4,809 across the US. 3% of them nationwide are listed as remote or flexible.
- Hiring the most in New Jersey
- Insmed Inc.6 open
- Actalent5 open
- CDM Smith5 open
- Experience
- This posting asks for at least 3 years of experience; Quality Assurance postings that state a minimum ask for 5 years at the median (3,704 postings).
- Education
- This posting asks for a bachelor's degree; 1,659 of the 4,809 open Quality Assurance jobs (34%) ask for a bachelor's degree or higher.
Counted across the open, public US postings on Olive Jobs on November 11, 2026. Pay medians are the middle values of the low ends and of the high ends of postings that list both ends of a range in the same cadence (a yearly salary or an hourly rate); a range's midpoint is halfway between its ends. Pay and experience figures resting on fewer than 20 postings are left out.
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