QA GLP, Contractor

At Proclinical, we are seeking an individual to fill the role of QA GLP, Contractor, based in Pennsylvania. This position is responsible for conducting quality assurance audit functions for regulated facilities.

Responsibilities

• Ensure Good Laboratory Practice (GLP) in relevant laboratories, and that all associated functions meet GLP requirements for nonclinical and clinical study sample analyses.
• Conduct internal audits according to internal audit program.
• Review and approve bioanalytical/toxicokinetic reports for compliance with GLP and company SOPs.
• Assist with external GLP bioanalytical and toxicology contract research organization audits as needed. Coordinate scheduling of external audits with CROs and consultants, generate audit agendas, review and follow up on responses, and close out audits.

Skills And Qualifications

• BA in scientific/life-sciences or related field.
• Quality Assurance experience in a Pharmaceutical or biotechnology environment with United States Food and Drug Administration (FDA) or another regulatory agency.
• Understanding of GLP regulations and experience with GLP requirements preferred.
• Knowledge of 21 CFR Part 11 regulations and guidelines is preferred.
• Strong written, verbal, and interpersonal communication skills.
• Strong knowledge of Microsoft Office and other relevant computer programs.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 6468786308 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.