Senior QA Auditor

BioAgilytix Boston, 1320 Soldiers Field Road, Boston, Massachusetts, United States of America Req #70
Friday, November 4, 2022
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, 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, and QA experience in a deadline-driven and regulated GxP 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

  • Perform Quality Assurance (QA) data audits, phase inspections, and monitor procedures against standard operating procedures, methods, protocols, guidance, and required regulations
  • Identify compliance gaps and provide recommendations for improvement in processes
  • Assist in reviewing deviations and investigations
  • Assist in developing annual regulatory refresher training

Minimum Preferred Qualifications


  • Bachelor’s degree in biology, chemistry, biochemistry, or other scientific discipline
  • Experience working in biotech, pharmaceutical, CRO, CMO or similar organization, with at least two (2) years’ experience working in a laboratory, bench role or bioanalytic operations
  • At least five (5) years’ experience in GLP/GCLP quality assurance role, with internal or external GxP auditing experience


  • Exhibit proficiency and comprehension of mathematical formulas
  • Ability to perform your role independently, with good sense and judgment and minimal oversight
  • Self-motivated and demonstrated ability to learn and work in a fast-paced environment
  • Expertise in communicating and building relationships with others, where all feel heard and respected

Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Paid Holidays (9 scheduled; 3 floating), 401k with Employer Match Employee Referral Program (up to $10k), Free Coffee, Tea, Fruit, and Snacks, Discounted Vending Machines (25 cents for everything!), Team Wellness Challenges/Events 
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

Other details

  • Pay Type Salary
Location on Google Maps
  • BioAgilytix Boston, 1320 Soldiers Field Road, Boston, Massachusetts, United States of America