Senior Quality Assurance Specialist -GMP Audits, Cambridge MA

Infinity Pharmaceuticals is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients first-in-class or best-in-class medicines for the treatment of cancer and related conditions.

Position Description:

The Senior Quality Assurance Specialist will work with Infinity project teams, contract manufacturing organizations, and contract testing laboratories to move products from research to preclinical to clinical trials in support of the company’s drug discovery and development efforts.  The Senior Quality Assurance Specialist will perform internal and external audits to ensure the Infinity as well as GLP, GCP and GMP vendors comply with applicable regulation.  This position will also back up other department members with batch record and study report review as well as writing and revising SOPs

Responsibilities:

·         Performing GMP, GCP and GLP vendor audits and setting audit schedules

·         Review and release clinical trial material.

·         Work closely with contract manufacturing organizations and contract testing laboratories to ensure cGMP compliance. 

·         Quality planning for moving products from research to preclinical to clinical trials including specification development, batch record creation/approval, and test method validation. 

·         Writing and revising SOPs

Requirements:

·         Minimum of a BS degree in a scientific discipline, preferably chemistry

·         5-6 years of Quality Assurance experience in regulated manufacturing, laboratory and/or clinical environments

·         Ideal candidates will be flexible and willing to travel up to 50%.

·         Proficiency in auditing at least one GXP function is a core requirement.

·         2-3 years auditing experience in either GMP, GCP or GLP.  Experience in multiple disciplines in preferred

·         Thorough knowledge and understanding of current Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) guidelines

·         Good Clinical Practices (GCP) experience a plus

·         Strong written and verbal communication skills, interpersonal skills, technical writing skills, and the ability to work well in a team environment

Infinity offers an outstanding benefits package and is an EOE.
Qualified candidates are encouraged to apply online at www.ipi.com/careers/html or email  This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

John Rynak
Infinity Pharmaceuticals
780 Memorial Drive
Cambridge, MA 02139
617-645-1345