Senior Quality Assurance Auditor

BioAgilytix Labs is a contract bioanalytical laboratory whose mission is the complete satisfaction of their pharma, biotech and agriculture clients’ needs in the discovery, GLP, GCP/GCLP and GMP areas for studies such as: (1) immunoassays, (2) pharmacokinetics, (3) immunogenicity, (4) biomarker analysis and (5) cell-based assays measuring downstream targets of small and large molecule drugs.

Position Description:

The principal responsibilities for this position are to:

Lead/conduct routine, in-phase, process, facility, vendor and computer/equipment systems audits and inspections
Write and issue audit reports and review responses to audit findings for appropriateness and completeness
Write and review Standard Operating Procedures
Maintain documentation and status of auditing activities
Assist in educating, guiding and influencing management and staff on best quality and compliance policies
Support regulatory and sponsor audits

Requirements:

Degree in biology, chemistry, or other scientific or related field with a minimum of five (5) years of experience in pharmaceutical / biotechnology / CRO preclinical / clinical quality assurance operations
Experience hosting regulatory/sponsor audits
Solid understanding and up to date knowledge of FDA and EPA GLP regulations, OECD Principles of Good Laboratory Practice, FDA GMP regulations and industry standards as they apply to the life sciences and pharmaceutical industries
Ability to work in a fast paced environment where multiple projects are in process and must be completed in a timely manner under minimal supervision
Excellent oral and written communication skills are essential
Proficient use of computer and Microsoft software programs