QA Data/Document Review Associate

American Regent • Columbus, OH

8h

About The Position

To provide a comprehensive Quality compliance review of cGMP analytical data and results for raw materials, in-process and finished product release, stability program results and summaries, and raw data related to the Validation of pharmaceutical processes. To facilitate corrections and clarifications to the reviewed data and provide a final approval of the records.

Requirements

• Bachelor’s degree in the Biological, Physical Sciences, Mathematics or related field or Associate Degree with experience in data review required.
• Minimum 2 years experience of microbiological experience in practices in areas such as gram stains, plate counts, manufacturing of media, environmental monitoring, and microbiological assays or at least 1 year of data review experience.
• Demonstrates extreme attention to detail to achieve quality results.
• Ability to perform multiple activities at the same time and producing outstanding results to meet required deadlines.
• Exercises a willingness to learn and take on added responsibilities as needed.
• Excellent organizational, interpersonal and communication skills (oral and written) to work in a team environment.
• Ability to work overtime as needed.

Responsibilities

• Provides quality assurance review of laboratory raw data and reports including environmental monitoring and microbiological worksheets, test summaries, and trending data (for microbiological related data).
• Participates in identifying quality process improvements to increase efficiencies and performance of systems, operations and personnel relating to the QA Data Review process.
• Writes and revises SOP’s and other GMP documentation as needed.
• Initiate and complete CR process.
• Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, compendia, and all applicable FDA Guidance document requirements and other company requirements.
• Perform cGMP training to analysts.
• Participates in other Quality System activities with other team members as needed.
• Perform any other tasks/duties as assigned by management.
• Embrace the QUALITY culture.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree