Entry Level QA Document Review Associate
The Entry Level QA Document Review Associate plays a critical role in ensuring pharmaceutical manufacturing quality by reviewing cGMP analytical data and laboratory records. Responsibilities include quality assurance reviews, SOP writing, deviation reporting, and maintaining compliance with regulatory standards. This onsite contract-to-hire position requires strong attention to detail, communication skills, and proficiency in documentation within a regulated environment.
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, pharmaceutical manufacturing & quality assurance.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
What You’ll Do
This position is part of the Environmental Condition Team supporting pharmaceutical quality assurance. As an Entry Level QA Document Review Associate you will perform quality compliance reviews of laboratory and environmental monitoring data, support corrective actions, and provide final approval of QA records.
- Provide quality assurance reviews of laboratory raw data and reports, including environmental monitoring and microbiology worksheets, test summaries, and trending data.
- Identify and recommend quality process improvements to increase system, operational, and personnel efficiency in QA data review.
- Write and revise SOPs and other GMP documentation as required; initiate and complete Change Requests.
- Maintain accurate records in LIMS and laboratory systems following Good Documentation Practices (GDP), SOPs, and policies.
- Assist with data collection for trending and report deviations or Out-of-Specification results.
- Communicate discrepancies or deviations promptly to supervision or management.
- Plan and prioritize daily workload to meet deadlines while maintaining compliance.
Qualifications
- Bachelor’s degree in Biological or Physical Sciences, Mathematics, or a related field — OR Associate degree plus relevant experience in data review.
- Strong attention to detail with a focus on producing high-quality, auditable records.
- Experience working with documentation in highly regulated industries (preferred).
- Proficient with Microsoft Office (Excel, Word, PowerPoint).
- Strong written and verbal communication, organization, and project-management skills.
- Ability to handle confidential information with integrity and discretion.
- Comfortable working independently and as part of a cross-functional team.
Preferred / Nice-to-Have
- Prior experience with LIMS or laboratory systems.
- Familiarity with cGMP, environmental monitoring, and QC Microbiology data.
- Experience drafting or revising SOPs and completing change-control paperwork.
Work Environment & Schedule
- This is a fully onsite role in Westerville, OH. Expect a primarily desk-based position with routine walking throughout the facility to gather data and information.
- Business-casual dress.
- Regular hours: 8:30 AM – 5:00 PM.
- Role type: Contract-to-hire (initial contract period with potential for direct hire).
Compensation & Benefits
- Pay: $24.00 per hour.
- Actual pay offered will depend on qualifications, experience, and other job-related factors.
- If eligible, benefits during/after the contract period may include medical, dental, vision, 401(k), life insurance options, disability coverage, HSA, transportation benefits, and paid time off — subject to plan terms and eligibility.
Location
- Onsite — Westerville, OH (workplace location per this posting).
Equal Employment & Accommodations
Careertakes and our client are committed to equal employment opportunity and will consider all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
If you require a reasonable accommodation during the application or interview process due to a disability, please notify Careertakes so we can work with our client to support your needs.
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.
Negotiate a higher salary! Check the salary ranges for this job type in your area.
View My Salary Range