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