Quality Labeling Specialist job in Philadelphia, USA

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

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

Proclinical is currently recruiting for a Quality Labeling Specialist with a pharmaceutical company located in Philadelphia, PA.

Job Responsibilities:

Act as QA lead and single point of contact for managing clinical label supplies.
Review and disposition of executed packaging and clinical labeling batch records and disposition of clinical batches.
Manage QA responsibilities related to QP release batch certification of EU clinical supplies.
Manage and track controlled document distributions to external CMOs.
Perform QA duties during management of supplier quality events such as investigations, change controls, CAPAs and complaints related to clinical supplies.
Manage product complaints lifecycle (receipt, process, investigate, track and closure) including internal and external communications.
Act as subject matter expert of internal eDMS / eQMS and provide training when needed.
Responsible for suppliers GMP oversight per company's procedures.
Ensure timely routing and processing of all GxP documents.
Negotiate Quality Agreements with third parties.
Develop and maintain company procedures.
Perform internal and external cGMP audits.
Provide support and participate in regulatory agency inspections.
Identify & alert QA Management of internal and external quality system issues.

Skills and Requirements:

Bachelors Degree Required
3-5 years of quality assurance experience within a biopharmaceutical environment
Knowledge of primary and secondary packaging configurations for global clinical studies.

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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