QA Documentation Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)
  3. United States
Frederick, USA
Posting date: 17 Aug 2020

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

Job Responsibilities:

  • Provides clerical and administrative support related to documentation processes and systems.
  • Pre-approves and routes documents for review and approval in the electronic Document Management System (DMS).
  • Approves Document Change Controls and assigns effective dates to documents.
  • Pre-Releases documents for training and adds documents to curricula in the electronic Learning Management System.
  • Maintains the document archival room.
  • Print process labels for Manufacturing.
  • Responsible for filing and maintenance of all controlled documents and records. Ensures files are accurate and easily retrievable.
  • Creates logbooks to be used in production.
  • Scans, verifies and archives documentation and records as needed.
  • Performs general word processing tasks. Checks format and conformance to document templates. Ensure the correct and timely input of database entries.
  • Provides support to clients on the process of documents in the DMS.and word processing tasks as needed.
  • Participates in function meetings.
  • Notifies manager of compliance questions and issues.
  • Provides additional support and assistance on tasks and projects as directed by management.

Skills and Requirements:

  • Bachelor's degree or Equivalent Experience - Current Good Manufacturing Practices (cGMP) and Pharma Industry Experience

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.