QA Auditor (6 Month Contract)

BioAgilytix • Durham, NC

4d

About The Position

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

We are seeking a Quality Assurance Auditor for a 6-month contract to support auditing activities at our Durham, NC laboratory. This role is ideal for candidates with experience working in a GxP-regulated environment who can quickly learn systems, evaluate processes, and ensure compliance with quality standards.

The ideal candidate is a strong critical thinker who brings a collaborative mindset and a commitment to scientific quality. If you thrive in a fast-paced environment, approach challenges with curiosity and ownership, and are passionate about ensuring the highest caliber of data for our clients, you’ll feel right at home at BioAgilytix.

Requirements

• Bachelor’s degree in biology, chemistry, biochemistry, medical technology, or other scientific discipline
• Not less than two (2) years’ experience working in a laboratory/bench role/operations
• Not less than two (2) years’ experience in GLP/GCLP quality assurance (QA)
• Experience working in biotech, pharmaceutical, CRO/CMO or similar organization

Nice To Haves

• Not less than two (2) years’ experience in GxP quality assurance (QA)
• Ability to work in a fast-paced environment where multiple projects are in process and must be completed in a timely manner
• Excellent verbal and written communication skills
• Ability to deal effectively with a diversity of individuals at all organizational levels
• Acute attention to detail
• Proficiency in Microsoft Office (Word, Excel, Outlook, etc.)

Responsibilities

• Performs Quality Assurance (QA) audits, inspections (in-phase as needed), and reviewing procedures against standard operating procedures, methods, protocols/plans, guidance documents, and/or regulations, as applicable
• Reviewing assay data (including equations, calculations, audit trails, etc.) and verifying reportable results on certificate(s) of analysis
• Reviewing laboratory investigations, out-of-specifications/expectations, deviations, and CAPAs, if applicable
• Reviewing assay qualification and validation reports
• Issue QA statements for reports as applicable
• Assist in writing and reviewing QA standard operating procedures
• Positively impacts the company through successful contributions, active participation and identification of compliance gaps
• Obtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks
• Assist in document management activities
• Perform duties with minimal QA Management oversight
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level