QA Auditor (6 Month Contract)

BioAgilytix•Durham, NC

1d•Onsite

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

Experience with GLP and GCP/GCLP regulations and applicable regulatory guidance
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