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Chemist II

Company: Prestige Consumer Healthcare
Location: Lynchburg
Posted on: March 16, 2020

Job Description:

Job Summary
Provide technical expertise and guidance to the Quality Control staff when performing chemical analyses on raw materials, in-process samples, finished products, and stability samples using established analytical methods, standards, and specifications. Troubleshoot, repair, and maintain laboratory and calibration equipment. Review and approve Finished Product, Raw materials and Stability paperwork. Lead training and instruction of Quality Control personnel.
Accountabilities

  • Complete testing according to SOPs, test methods and GMP requirements.
  • Notify management of OOS test results immediately.
  • Ensure documentation is complete and correct and all raw data maintained and calculations are completed.
  • Perform as a back-up for all QC Finished Product releases to QA. Release Raw materials and review Stability paperwork.
  • Ensure training has been completed for all individuals performing testing in the QC Chemistry lab.
  • Perform and assist with Validation Activities.
  • Regularly update Calibration database (eMaint or equivalent), schedule and perform calibration and verification activities.
    Responsibilities
    • Lead training and instruction of the QC personnel, review results for accuracy and completion, and provide technical leadership to the department.
    • Develop, coordinate, and perform the validation function for QC analytical procedures and laboratory equipment and assist with validation activities of product manufacturing systems.
    • Coordinate or perform a variety of analytical tests to assure compliance with established standards and specifications.
    • Review and approve raw materials, in-process, finished product, and stability paperwork.
    • Detect, investigate, and report technical Chemical problems & OOS investigations and initiate incident reports when required.
    • Create and review procedures.
    • Schedule all calibration and qualification activities involving outside vendors, including sending instruments to outside laboratories for repair or maintenance, and tracking their completion. Schedule outside vendors to perform annual preventive maintenance, qualification, and calibrations as appropriate. Interact with vendors as necessary to ensure instruments are operational with minimal down time.
    • Maintain and renew all service contracts with outside vendors. Provide timing to Quality management for renewals and budget purposes.
    • Ensure regularly scheduled verification and calibration activities are performed.
    • Maintain QC Laboratory analytical standards, including USP, secondary and calibration standards. Ensure secondary standards are qualified according to Fleet Laboratory procedures.
    • Perform a variety of related record keeping and reporting functions.
    • Create laboratory reports for APR documents.
    • Participate in the auditing of the laboratory and procedures to comply with cGMPs, OSHA, and EPA regulatory requirements.
    • Involved in method transfer, method validation test, writing protocols
    • Involved in testing & review on special projects.
    • Involved in micro cross training & document review.
    • Involved in lab change control whenever there are any equipment moves from one lab to another lab, equipment decommission. Requires the knowledge gained through a BS degree in Chemistry, or the equivalent and a minimum of six years of experience in a Quality Control Laboratory.

Keywords: Prestige Consumer Healthcare, Lynchburg , Chemist II, Other , Lynchburg, Virginia

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