Who are we?
They were working independently under the supervision of the QC Laboratory Supervisor. The incumbent having advanced knowledge of analytical chemistry (USP/NF, BP/EP) and GMP/cGMP testing requirements, coordinates audits and performs release activities associated with all analytical testing (Raw Materials, Finished Products, Stability, Packaging Components, Microbiology) served in the Quality Control Laboratory. In addition, the incumbent will be required to audit instrument calibration records.
Duties and responsibilities include but are not limited to:
- Responsible for the final analytical release assessment of raw materials, finished products, in-process, packaging components, Technical Services, Process Validation, and stability samples
- Reviews and checks analytical reports, operational/instrumental parameters, formulae, calculations, chromatograms, and printouts related to raw materials, finished products, stability, packaging component, and microbiological testing by ensuring that work by the lab has been carried out by specifications, analytical methodology (compendia and in-house), standard operating procedures, training and qualification programs and the GMP/cgmps.
- Coordinates and ensures that all the applicable documentation from multiple specialized testing groups within QC related to a project’s testing is compiled and organized before rule before filing the analytical documentation.
- Responsible for auditing instrumentation calibration records by approved standard operating procedures and training and qualification programs.
- Responsible for electronic signature audit entries in the Laboratory Information Management System (LIMS), Empower, Trackwise, and SAP.
- Audits all electronic records in LIMS, Empower, and Trackwise before authorizing components in LIMS.
- Responsible for Data Integrity Audits on analytical instruments in the QC Laboratory.
- Minimum College or University Degree in Chemistry or a related field.
- Advanced knowledge of technical requirements per compendia (USP/NF, BP/EP), in-house methods, and general QC laboratory procedures and investigations.
- Knowledgeable in GMP/cGMP regulations as they apply to laboratories.
-Advanced knowledge of analytical instrumentation (ex. HPLC, UPLC, GC, Dissolution), CDS (Chromatography Data System) -Laboratory Information Managements system (LIMS), Empower, SAP, Laboratory Instruments.
- Product Knowledge, Laboratory compliance standards
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