Quality Assurance Specialist job in Wilmington, USA

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP)

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

#LI-BC1

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