QA Auditor I/II

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 at our Durham, NC laboratory. This role is ideal for candidates with experience working in a GxP and/or GMP 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.

Minimum Required Qualifications - Education and Experience (QA Auditor I):
• 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/GMP quality assurance (QA)

• Experience working in biotech, pharmaceutical, CRO/CMO or similar organization

Minimum Required Qualifications - Education and Experience (QA Auditor II):
• 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 three (3) years’ experience in GLP/GCLP/GMP quality assurance (QA)

• Experience working in biotech, pharmaceutical, CRO/CMO or similar organization

Minimum Preferred Qualifications - Skills and Experience:
• Experience with GLP and GCP/GCLP/GMP regulations and applicable regulatory guidance

• Not less than two (2) years’ experience in GxP/GMP 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.)

Supervisory Responsibility:
• This position has no supervisory responsibilities

Supervision Received:
• Frequent supervision and instructions

• Infrequently exercises discretionary authority