QA Auditor (6 Month Contract)

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.

Essential 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

Additional Responsibilities

• Other duties as assigned

Minimum Required Qualifications- Education and Experience

• 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

Minimum Preferred Qualifications- Skills and Experience

• 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.)

Supervisory Responsibility

• This position has no supervisory responsibilities

Supervision Received

• Frequent supervision and instructions
• Infrequently exercises discretionary authority

Working Environment

• Primarily office
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
• Occasional weekend, holiday, and evening work required

Physical Demands

• Ability to work in an upright and /or stationary position for up to eight (8) hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment
• Occasional mobility needed
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects including office materials and laptop computer with a maximum lift of 20 pounds
• Ability to access and use a variety of computer software
• Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Requires multiple periods of intense concentration
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
• Ability to perform under stress and multi-task
• Regular and consistent attendance

Position Type and Expected Hours of Work

• This is a 6 month, full time contract position
• Some flexibility in hours is allowed, but the employee must be available during the "core" work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.