GMP Pharmaceutical Data Review Specialist

about 1 month ago
Full time role
In-person · West Point, PA, US... more
  • Administrative support in reconciliation of controlled worksheets.
  • Experience working in dynamic environments where flexibility is essential
  • Assist different LOCV departments on an ad-hoc basis to ensure smooth functioning of operations
  • Independent auditing of laboratory data to ensure that regulatory compliance is maintained.
  • Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.
  • Foster a customer service attitude within and among laboratory personnel.
  • Ensure the laboratory data is in compliance with cGMPS, GLPs, and departmental procedures and assay methods and is of the highest integrity, quality and accuracy.
  • Review laboratory notebooks, logbooks, and CTU records to ensure compliance to data integrity and accuracy.
  • Complete the remediation activities of all data reviews to ensure errors are appropriately corrected and documented following departmental and site procedures.
  • Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia, etc.).
  • Works with laboratory staff and management to remediate comments and errors in documentation.
  • May assist in conducting investigations associated with laboratory data review.