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PDS Tech Inc Batch Record Reviewer in Frederick, Maryland

PDS Tech, Inc. is seeking Batch Record Reviewer

Job Description

The Batch Record Reviewer works as part of the QA team at our Frederick, Maryland facility. This persons core responsibility will be reviewing Device History Records and associated documents prior to release and shipment to ensure all requirements and specifications are met.

Review Device History Records (DHRs) and associated documents to ensure that all documents and specifications are met. Identify non-conformances and trend/report device history batch issues.

  • Ensures activities and items are in compliance with both company quality assurance standards and applicable quality system regulations. Resolve incomplete or unexplained issues found during the batch review with manufacturing.

  • Review finished good batch records and perform finished good inspections as required

  • Verify finished good labels for accuracy

*Minimum Qualifications (must have)

  • Bachelor's Degree in Scientific/Technical field (i.e. Chemistry, Biology, or Engineering) or equivalent.

  • Working experience in a regulated industry.

  • Effective communication skills are required, both written and verbal.

*Preferred Qualifications (nice to have)

  • 2 year experience in IVD, Medical Device or Pharmacuetical industry

  • Working knowledge of cGMP and it's appropriate application.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.