We are looking for a QC Data Reviewer (Associate Level Senior Level) who can ultimately perform data reviews to support release, stability programs, and lab operation within Quality Control.
This role continuously strives to follow all pertinent regulatory agency guidelines to drive performance. This position is a Tuesday Saturday8am-4 : 30pm schedule.
As the QC Data Reviewer, a typical day might include the following :
- Executing detailed data review for analytical test results generated by QC for compliance with cGMP, internal SOPs and Specifications
- Supporting production, stability studies, and lab operations
- Reviewing release and stability data, trend charts of reference standards, lab equipment calibration records and logbooks
- Performing detailed data review for analytical test results created by contract testing labs to assure correctness and accuracy
- Maintaining and updating relevant SOPs for data review and reporting
- Collaborating with Stability and other groups to support stability report writing and regulatory updates
- Participating in all vital training activities
This role might be for you if :
- You are results-oriented and can optimally analyze data trends
- You can work efficiently as an individual as well as with others
- You are a strong communicator who is willing to build beneficial relationships with other peer groups
To be considered for this role, you must have a BS / BA in Chemistry, Biology, or related field. You must be willing and able to work Tuesday Saturday 8am-4 : 30pm.
We may substitute other proven experience in lieu of a degree. Level will be determined by demonstrated experience. We need someone who has a solid understanding of data reviewing and regulatory agency guidelines.
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