Senior QA Specialist — Supplier Quality & Compliance (Remote)

SAB; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

SAB BIO is seeking a Sr. QA Specialist – Supplier Quality to lead qualification and ongoing quality oversight of third parties, including suppliers, service providers, and CDMOs, in a biotech environment.

With 5+ years of experience, you will manage investigations, CAPA, change control, and regulatory support while mentoring junior staff. The role includes leading audits, ensuring compliance with cGMP and internal standards, and driving continuous improvement across QA systems and manufacturing

Qualifications

• BS/BA in life sciences.
• 5+ years of quality assurance in a regulated manufacturing environment.
• Experience qualifying and overseeing GMP suppliers and service providers.
• Experience with GLP and GCP providers is a plus.
• Strong communication skills; proficient in MS Office (Word, Excel, PowerPoint, Outlook).
• Able to aseptically gown on the floor.
• Familiar with eQMS functionality; eQMS implementation experience desirable.
• Willingness to travel ~50% domestically and internationally.

Responsibilities

• Lead risk-based qualification and requalification of third parties, including audits and approvals.
• Manage ongoing third-party quality oversight, CPAs, and follow-up on quality issues.
• Maintain third-party qualification records and ensure timely reviews.
• Audit scope planning, reporting, and corrective action follow-up for contractors.
• Oversee QA on manufacturing and QC operations, including batch record review and deviations.
• Present quality metrics and training initiatives to leadership.
• Own quality systems (change control, CAPA, document management) and drive process improvements.
• Write, review, and approve SOPs, batch records, and work instructions.
• Perform batch disposition by reviewing records, tests, CoAs, and investigations.
• Inspect and approve raw materials and packaging components against specs.
• Provide QA floor support during manufacturing as needed.
• Domestic and international travel to supplier/CDMO locations.

Skills

QA experience

GMP knowledge

Communication skills

MS Office

Presentation skills

Aseptic handling

eQMS familiarity

Education

BS/BA in life sciences

Tools

eQMS

Job description

SAB BIO is seeking a Sr. QA Specialist – Supplier Quality to lead qualification and ongoing quality oversight of third parties, including suppliers, service providers, and CDMOs, in a biotech environment.

With 5+ years of experience, you will manage investigations, CAPA, change control, and regulatory support while mentoring junior staff. The role includes leading audits, ensuring compliance with cGMP and internal standards, and driving continuous improvement across QA systems and manufacturing