Entry Level QA Document Review Associate

About the Role

The QA Document Review Associate is a vital part of the Environmental Condition Team, responsible for ensuring the manufacture of safe and effective pharmaceuticals. This role involves performing quality compliance reviews of cGMP analytical data and results from the QC Microbiology and Environmental Monitoring team, facilitating corrections and clarifications, and providing final approval of records.

Key Responsibilities

• Provide quality assurance reviews of laboratory raw data and reports, including environmental monitoring and microbiological worksheets, test summaries, and trending data.
• Participate in identifying quality process improvements to enhance system, operation, and personnel efficiencies related to the QA Data Review process.
• Write and revise SOPs and other GMP documentation as needed and initiate and complete the Change Request process.
• Maintain accurate records of work performed in LIMS and Laboratory systems according to Good Documentation Practices, SOPs, and policies.
• Assist with data for trending and report deviations from Out-of-Specification results.
• Communicate any discrepancies or deviations to supervision or management upon discovery.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements.
• Plan daily workload to meet requirements and maintain compliance with all required SOPs.

Requirements & Tech Stack

• Bachelors degree in Biological, Physical Sciences, Mathematics, or a related field, or an Associate Degree with experience in data review.
• Extreme attention to detail to achieve quality results.
• Experience in documentation and highly regulated fields.
• Excellent communication, organization, and project management skills.
• Proficiency in Microsoft Office (PowerPoint, Excel, Word).
• Ability to work independently and collaboratively in a diverse and inclusive environment.
• Handling confidential information with the ability to maintain confidentiality.

Preferred Qualifications

• Experience in documentation is preferred.
• Experience in highly regulated fields is preferred.

Work Environment & Schedule

• This position is primarily desk-based but requires walking around the facility to collect data and information.
• The dress code is business casual.
• The work hours are from 8:30 AM to 5:00 PM.
• This is a fully onsite position in Columbus, OH.

Job Type & Location

• This is a Contract to Hire position.
• Location: Columbus, OH.

Pay & Benefits

• Pay Range: $24.00 - $24.00/hr.
• Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change.
• Available Benefits (if eligible): Medical, dental & vision, Critical Illness, Accident, and Hospital, 401(k) Retirement Plan, Life Insurance, Short and long-term disability, Health Spending Account (HSA), Transportation benefits, Employee Assistance Program, Time Off/Leave (PTO, Vacation or Sick Leave).

Application Deadline

• Anticipated to close on Oct 31, 2026.