QA Documentation Specialist

Proclinical is currently recruiting for a QA Documentation Specialist position in the Frederick, MD area with a globally leading pharmaceutical company. A successful candidate with have a bachelor's degree, experience within the pharmaceutical industry, and sound knowledge of GMPs/cGMP.

Job Responsibilities:

• Provide clerical and administrative support related to documentation processes and systems
• Pre-approve and route documents for review and approval in the electronic Document Management System (DMS)
• Approve Document Change Controls and assigns effective dates to documents
• Pre-Release documents for training and adds documents to curricula in the electronic Learning Management System
• Maintain the document archival room
• Responsible for filing and maintenance of all controlled documents and records. Ensure files are accurate and easily retrievable
• Create logbooks to be used in production
• Scan, verify and archive documentation and records as needed
• Perform general word processing tasks. Check format and conformance to document templates. Ensure the correct and timely input of database entries
• Provide support to clients on the process of documents in the DMS and word processing tasks as needed
• Participate in function meetings
• Notify manager of compliance questions and issues
• Provide 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

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643

or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

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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