At ProClinical, we are seeking an individual to fill the role of Quality Assurance/GLP, based in Wilmington, DE. This position is responsible for conducting quality assurance audit functions for Good Laboratory Practice (GLP) regulated facilities.
- Ensure Good Laboratory Practice (GLP) bioanalytical, toxicokinetic and pharmacokinetic laboratories and associated functions meet all GLP requirements for nonclinical and clinical study sample analyses.
- Conduct internal audits.
- Review and approve bioanalytical/toxicokinetic reports for compliance with GLP and company SOPs.
- Assist with external GLP bioanalytical and toxicology contract research organization (CRO) audits.
- 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.
- QA experience in a Pharmaceutical or biotechnology environment with United States Food and Drug Administration (FDA) or other regulatory agency.
- Understanding of GLP regulations and experience with GLP requirements for the bioanalytical testing of small and large molecule drug substance in regulated nonclinical studies preferred.
- Knowledge of 21 CFR Part 11 regulations and guidelines is preferred.
- Strong written, oral communication, interpersonal, and organization skills.
- Proficiency in Microsoft Office and software systems including Watson, Phoenix, WinNonlin, etc.
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 Mary Jacobs at (+1) 2674774800 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.