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 applicableReviewing assay data (including equations, calculations, audit trails, etc.) and verifying reportable results on certificate(s) of analysisReviewing laboratory investigations, out-of-specifications/expectations, deviations, and CAPAs, if applicableReviewing assay qualification and validation reportsIssue QA statements for reports as applicableAssist in writing and reviewing QA standard operating proceduresPositively impacts the company through successful contributions, active participation and identification of compliance gapsObtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networksAssist in document management activitiesPerform 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 guidanceNot 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 mannerExcellent verbal and written communication skillsAbility to deal effectively with a diversity of individuals at all organizational levelsAcute attention to detailProficiency in Microsoft Office (Word, Excel, Outlook, etc.)
Supervisory Responsibility
This position has no supervisory responsibilities
Supervision Received
Frequent supervision and instructionsInfrequently exercises discretionary authority
Working Environment
Primarily officeRoutinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsOccasional 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 dayRepetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipmentOccasional mobility neededOccasional crouching, stooping, with frequent bending and twisting of upper body and neckLight to moderate lifting and carrying (or otherwise moves) objects including office materials and laptop computer with a maximum lift of 20 poundsAbility 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 sentencesFrequently interacts with others to obtain or relate information to diverse groupsRequires multiple periods of intense concentrationPerforms a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrenceAbility to perform under stress and multi-taskRegular and consistent attendance
Position Type and Expected Hours of Work
This is a 6 month, full time contract positionSome flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee HandbookOccasional weekend, holiday, and evening work required