Quality Assurance Specialist
Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Wilmington, DE.
- Act as QA lead and single point of contact for managing small molecule products.
- Implement and maintain Quality Systems, Global policies and procedures.
- Develop, implement and maintain Incyte procedures.
- Act as a knowledge manager of internal eDMS / eQMS and provide training when needed.
- Review and disposition of suppliers executed drug substance and drug product batches intended for use in clinical studies during clinical development stage.
- Perform QA duties during management of supplier quality events such as investigations, change controls, CAPAs and complaints related to clinical development projects.
- Review Regulatory documentation, such as NDAs, INDs and IMPD, as well as responses to Health Authority questions as needed.
- Report and maintain Quality Management System metrics associated with his/her responsibilities, as needed.
- Manage and track controlled document distributions to external CMO's
- Perform QA role during management of internal Quality Events records in Veeva such as audits, deviations, CAPAs and change controls as needed.
Skills and Requirements:
- Bachelors Degree required
- 3-5 Years experience working within a biopharmaceutical environment
- Knowledge of GMP regulations
- Experience working within EDMS, QMS, and DMS
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.