Company: Prestige Consumer Healthcare
Posted on: March 16, 2020
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
- Complete testing according to SOPs, test methods and GMP
- 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.
- 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
- 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
- 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
- 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
- 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
Keywords: Prestige Consumer Healthcare, Lynchburg , Chemist II, Other , Lynchburg, Virginia
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