Quality Assurance Specialist

Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Wilmington, DE.

Job Responsibilities:

• 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.

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