QA Data/Document Review Associate
On-site · Columbus, Ohio, United States
Job Summary
QA Data/Document Review Associate responsible for comprehensive quality compliance review of cGMP analytical data and results across raw materials, in-process, and finished product release, and stability program results. Performs QA review of laboratory raw data, environmental monitoring, microbiological worksheets, test summaries, and data trending; identifies process improvements; writes/revises GMP documentation; initiates/completes CR processes; ensures work complies with cGMP and FDA guidance; provides training to analysts; collaborates within Quality Systems; supports routine quality duties and other tasks as assigned. Emphasis on accuracy, data integrity, and timely delivery within a regulated pharmaceutical environment.
Required Qualifications
- Bachelor’s degree in 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
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