Frontage Laboratories has an excellent opportunity for a Quality Assurance Specialist working with the Bioanalytical services group at its Malvern, PA site. The successful candidate will have a BS/MS degree in pharmaceutical sciences, chemistry, or biological sciences and at least 3-5 years of experience in the pharmaceutical industry including experience in bioanalysis and / or monitoring bioanalytical work, or equivalent experience as a GLP quality assurance auditor.

Responsibilities will include, but are not limited to:

	Conduct QA audits including but not limited to: in-process, data review, and technical report audits for bioanalytical studies, and study-independent facility / process audits.
	Maintain appropriately detailed notes, schedules, audit reports, and records
	Effectively report quality issues to the QA Director, lab personnel, Study Director, and Frontage management, as appropriate.
	Implement, maintain and enhance quality procedures and systems to ensure compliance with US FDA and OECD regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, and other relevant guidances and publications.
	Provide compliance training to staff as necessary.
	Assist the QA Director with external client and regulatory audits / inspections

Frontage Laboratories, Inc. is a collaborative R&D company dedicated to advancing the development efforts of pharmaceutical companies around the world with our expertise in Preclinical, Clinical Pharmacology, CMC services including formulation development, pharmaceutical analysis and clinical trial supply (sterile liquids and solids), Clinical Phase I, and Bioanalytical services. We specialize in assisting our partners to resolve complex product development challenges through our integrated services with facilities in the United States and China.

Please submit your résumé to SBROOKS@frontagelab.com