Job Description

Hiring for both a Level 1 and Level 2 Specialist, depending on experience, pay range reflects both roles.

The Quality Assurance Specialist - Document Control will create, format, revise and proofread controlled documents such as Standard Operating Procedures (SOPs), Forms, Validations, etc. from departments including but not limited to Quality Assurance, Manufacturing, Facilities, and Quality Control. Perform general office duties such as photocopying, word processing, filing, scanning, physical inventory, ordering supplies.

Qualifications

• Create, format, revise and proofread controlled documents such as Standard Operating Procedures (SOPs), Forms, Validations, etc. from departments including but not limited to Quality Assurance, Manufacturing, Facilities, and Quality Control.
• Enforce limited access restrictions of secured controlled documents in the electronic and physical document locations.
• Process documents for approval signatures, official distribution, and absolution.
• Assist with maintaining inventory of on-site documentation.
• Assist with the maintenance of document retention and destruction schedules.
• Perform general office duties such as photocopying, word processing, filing, scanning, physical inventory, ordering supplies, etc.
• Proficient in cGMPs.
• Proficiency in computer systems requirements, validations, role and training assignments.
• Willingness to take on new projects.

Education Requirements :

High School diploma required.

Experience Requirements:

Minimum of one year of experience for level 1, 3+ years for level 2 in the pharmaceutical or biotechnology industry and document management systems and software.

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