Location: Exton PA
Reports to: Director BIO GLP Quality assurance
Full-time
Position/Job Summary:
Are you ready for a role that will combine your thirst for scientific knowledge and eye for quality. Then you are the perfect fit for our team of quality associates whose audits contribute to the award-winning services provided by Frontage Laboratories Inc. The Quality Assurance Specialist works closely with the scientists and management auditing research studies that support modern medicine in support of finding cures or treatments of diseases.
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Roles & Responsibilities:
- The QA Specialist conducts QA audits of BIO laboratories and functions including but not limited to ongoing process, data review audits, technical report, and study independent facility / process.
- The QA specialists reports quality issues to QA management, Study Director and laboratory management as appropriate.
- QA Specialist will maintain audit detailed notes, reports and records on Frontage Systems.
- Review, support and maintain Standard Operating Procedures.
- Provide oversight and input to investigations and CAPA as appropriate.
- Support and train staff on GLP regulations and SOPs as needed.
Education, Experience & Skills Required:
- Working knowledge of US FDA, OECD, and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, and other relevant guidance and publications. One of our groups also works to 40 CFR part 160.
- BS/BA in a relevant scientific discipline experience may substitute for minimum education requirement.
- Experience in quality systems and quality assurance processes, development and documentation.
- Experience in Bio-Analytical Laboratory preferred.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Skills Required
- Working knowledge of US FDA, OECD, and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, and 21 CFR Part 320
- Experience conducting QA audits in bioanalytical or BIO laboratories
- Experience with quality systems, QA processes, documentation, and CAPA management
- Maintain audit notes, reports and records in Frontage Systems
- BS/BA in relevant scientific discipline (or equivalent experience in lieu of degree)
- Experience in a bio-analytical laboratory
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
