QA Data Review Specialist

Actalent; Columbus (OH); On-site; USD 27,000 - 39,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Paid time off

Job summary

Actalent in Columbus, OH is seeking a QA Document Review Associate to ensure the manufacture of safe pharmaceuticals. You will perform quality compliance reviews of cGMP analytical data from QC Microbiology and Environmental Monitoring, facilitate corrections, and provide final approval of records.

The role emphasizes attention to detail, documentation, and communication as you work with LIMS and laboratory systems, write SOPs, and support trending and deviation reporting.

Qualifications

• Bachelor's degree in Biological, Physical Sciences, Mathematics, or a related field, or an Associate Degree with data review experience.
• 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.

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.

Skills

Attention to detail

Documentation

Communication

Project management

Microsoft Office

Collaboration

Confidentiality

Education

Bachelor's degree in Biological/Physical Sciences or related field

Associate Degree with data review experience

Tools

LIMS

Laboratory systems

Job description

Actalent in Columbus, OH is seeking a QA Document Review Associate to ensure the manufacture of safe pharmaceuticals. You will perform quality compliance reviews of cGMP analytical data from QC Microbiology and Environmental Monitoring, facilitate corrections, and provide final approval of records.

The role emphasizes attention to detail, documentation, and communication as you work with LIMS and laboratory systems, write SOPs, and support trending and deviation reporting.