QA Auditor - GMP/CMC

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. In this role, you will champion quality and compliance in our solutions. Our clients trust us to deliver excellence in data and bioanalysis, and this role is the last destination before our data is delivered. You will ensure standard methods and protocol requirements are met through thorough monitoring and audits. Partnering with the Operations team, you will review key procedures in a GxP environment, with focus on GMP, highlight any gaps or deviations in approach, then advise on corrective action, which leads us to the ultimate goal of data quality and integrity for our customers.   We are looking for candidates who have large molecule, bioanalytical, data review and preferable QA experience in a deadline-driven and regulated GMP setting. The best candidates are fast learners, quantitative thinkers, and doers. If you are a person who influences others in a way that feels like a trusted advisor and advocate, is energized by collaboration, sees the big picture, and aspires to provide the best caliber of data to our customers, then you’ll be right at home here 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, or other scientific discipline

Not less than two (2) years’ experience working in a laboratory/bench role/operations

Minimum Preferred Qualifications - Skills and Experience

Not less than two (2) years’ experience in GMP quality assurance (QA)

Experience with GMP regulations, including 21 CFR, ICH, USP, etc.

Experience with GMP assays, including review of data in a Chromatography Data Systems (CDS), i.e., Chromeleon, review and release of multi-component certificates of analysis, HPLC, capillary electrophoresis (CE), mass spectrometry, UV/Vis, USP compendial assays, ELISA, PCR, and/or potency

Internal and/or external GMP data auditing/review experience

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