Quality Labeling Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
  3. United States
Philadelphia, USA
Posting date: 02 Mar 2021

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.