QA Documentation Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)
  3. United States
Gaithersburg, USA
Posting date: 26 Oct 2020
QA.CN.33786

Proclinical is currently recruiting for a QA Documentation Specialist with a pharmaceutical company located in Gaithersburg, MD.

Job Responsibilities:

  • Maintain a document management system aligned with regulatory, quality, and company requirements.
  • Responsible for the management of all documentation and records issuance and archival processes to support manufacturing process.
  • Manage effective documents including procedures, forms, specifications, and batch documentation.
  • Manage document control inventory supply and place requisitions.
  • Collaborate with cross-functional departments to ensure timely implementation of document change controls and requests.
  • Assign lot related documentation and labels for manufacturing process.
  • Print, compile and issue all lot-related documentation (batch records, labels, sample plans, specifications etc.)
  • Own Document Control-specific quality records, including deviations, CAPA, batches and audit responses.
  • Responsible for improving, executing and maintaining the document change control system.
  • Investigate deviations against the document management system and develop effective corrective action plans.
  • Provides troubleshooting assistance for users regarding documents in Learning Management Systems (LMS) and accessing training items.
  • Identify and raise compliance gaps across the document management system.
  • Develop and conduct training to new staff on document management processes, procedures and label issuance.
  • Support audits (internal, external) with document management.

Skills and Requirements:

  • Pharmaceutical experience, experience with electronic document management systems (Learning Management Systems (LMS) is a plus), and Document Control of specific quality records to support manufacturing processes, including deviations, CAPA, batch records and audit responses.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

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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