- 190043 - Batch Record Reviewer
- 12 months
- Chipton-Ross is seeking a Batch Record Reviewer for an opening in Fredrick, MD.
Review Device History Records (DHR’s) 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
2 year experience in IVD, Medical Device or Pharmacuetical industry
Working knowledge of cGMP and it's appropriate application.
Working experience in a regulated industry.
Effective communication skills are required, both written and verbal.
Bachelor's Degree in Scientific/Technical field (i.e. Chemistry, Biology, or Engineering) or equivalent.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
6926 Rivers Ave
North Charleston, SC 29406
Phone: (843) 554-5800 x332 or (800) 927-9318 x332
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.