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