Entry Level QA Document Review Associate
The QA Document Review Associate plays a critical role in ensuring pharmaceutical manufacturing quality by reviewing cGMP analytical data and microbiological reports for compliance. This position involves quality assurance reviews, documentation management, SOP writing, and collaboration to maintain regulatory standards and improve quality processes. The role is contract-to-hire, based onsite in Columbus, OH, requiring attention to detail and strong communication skills.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
Position Overview
This Contract-to-Hire, entry-level QA Document Review Associate position supports pharmaceutical quality assurance by performing cGMP reviews of laboratory and environmental monitoring data. The role is onsite in Westerville, OH and involves working with QC Microbiology and Environmental Monitoring teams to verify records, document corrections, and ensure compliance with Good Manufacturing Practices.
Responsibilities
- Provide quality assurance reviews of laboratory raw data and reports, including environmental monitoring and microbiological worksheets, test summaries, and trending data.
- Identify opportunities for QA process improvements to enhance system, operational, and personnel efficiencies.
- Write and revise SOPs and other GMP documentation as needed; initiate and complete change requests.
- Maintain accurate records in LIMS and laboratory systems following Good Documentation Practices, SOPs, and policies.
- Assist with data trending and report deviations from Out-of-Specification results.
- Communicate discrepancies or deviations promptly to supervision or management.
- Ensure all work is performed and documented in accordance with company policies, procedures, Current Good Manufacturing Practices, and health & safety requirements.
- Plan daily workload to meet requirements and maintain compliance with applicable SOPs.
Essential Skills & Qualifications
- Bachelor’s degree in Biological, Physical Sciences, Mathematics, or related field — OR Associate degree with relevant experience in data review.
- Extreme attention to detail and strong data integrity mindset.
- Experience in documentation within highly regulated environments (preferred).
- Excellent written and verbal communication, organization, and project-management skills.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint).
- Ability to work independently and collaboratively in a diverse, inclusive environment.
- Ability to handle confidential information appropriately.
Additional Skills & Preferences
- Prior experience with LIMS or laboratory data systems (preferred).
- Experience in pharmaceutical or other regulated manufacturing environments (preferred).
Work Environment & Schedule
- Fully onsite role based in Westerville, OH.
- Primarily desk-based with facility walk-throughs to collect data and information.
- Business-casual dress code.
- Typical hours: 8:30 AM – 5:00 PM.
Job Type & Location
- Contract to Hire
- Full-time, Onsite — Westerville, OH (United States)
Compensation & Benefits
- Pay range: $24.00 per hour (range: $24.00 - $24.00/hr).
- Actual compensation within the posted range will depend on experience, qualifications, and other job-related factors.
- If eligible, benefits may include: medical, dental & vision; 401(k) plan; voluntary life & AD&D; short- and long-term disability; HSA; transportation benefits; Employee Assistance Program; and paid time off — eligibility depends on role and employment status.
Note on Application Process
Careertakes is acting as a third-party recruiter for this opening. Please do not include direct employer contact details in application materials here. All candidate communications and hiring decisions are handled by the client’s hiring team.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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