Documentation Specialist

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation specialists will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites. The document control specialist provide documentation control support for our clients’ quality assurance department.

Responsibilities include:

• File, scan and organize Quality Assurance, Validation and Facilities documents
• Provide support for any documentation control compliance issues
• Ensure procedures are in place and maintained properly as per GMP
• Provide improvements to current Quality Assurance documentation control program
• Assist Client personnel with maintaining GMP documentation
• Work closely with Quality and Facilities to address any documentation discrepancies

Skill Level and Requirements:

• Experience with filing, scanning, and organizing GMP documentation
• experience with an electronic document management system
• Experience with Microsoft Office and Adobe Acrobat
• Good communication skills

Minimum Requirements:

• Bachelor of Science in one of the life sciences
• 1-2 years of direct experience and/or training in a regulated environment in Quality Assurance, Quality Control, Compliance, or Manufacturing
• GMP compliance knowledge
• Current driver’s license and auto insurance

Quality Agents offers a full suite of benefits for full-time employees including:

• Health, dental and vision insurance
• Life, AD&D and Disability Insurance
• Health savings account for participants in our health plan
• 401k retirement plan
• Paid time off
• Paid holidays