Quality Labeling Specialist

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

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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