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.

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 (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

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 full-time 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

Learn more about this Employer on their Career Site

QA Auditor I/II