GMP Data Reviewer

2 days ago
Full time role
King of Prussia, PA, US... more
King of Prussia, PA, US... more

Job Description

  • Water Systems
    • GMP review of microbiological testing of the facility and/or laboratory water purification system samples. Tests included are LAL and Bioburden.
    • GMP review of analytical testing of the facility and/or laboratory water purification system samples. Tests included are TOC, Conductivity, EU WFI Chemical Testing.
    • GMP review of Qualification and Media Release testing.
    • GMP review of facility cleaning data and in-processing testing, including but not limited to endotoxin, bioburden, BI, HPLC, Protien Concentration, pH and Osmolality.
    • Initiation and follow-up of exceeded alert and action limits per procedures.
    • Participate in preparation of quarterly trending reports​
  • Raw Materials
    • GMP review of general appearance/identifications and FTIR
    • GMP review of house gas/air sampling and testing
    • Initiation and follow-up of OOS and action limits per procedure
    • Electronic and physical receipt, log-in and distribution of samples and testings materials coming into QC.
    • Discarding / completing sample custody chain
    • Preparation and shipping of sample/materials
    • Aliquoting of bulk samples, assay standards, assay controls and custom assay reagents
  • Laboratory Support
    • Assist in updating and writing SOP's
    • Routine calibration and maintenance of laboratory equipment which includes pipettes, balances, plate readers and pH meters
    • Cleaning of incubators, laminar flow hoods and biosafety cabinets
    • Cleaning of refrigerators and cold rooms
    • Defrosting of freezers
    • Disinfectant preparation
    • Maintenance of solvent wash bottles
    • Cleaning of water baths
    • GMP lab sweeps
    • Equipment out-of-tolerance (OOT) and refrigerator, freezer, incubator and pipette investigations
    • Weekly distributed control system (DCS) documentation review and maintenance
    • Participate as required in any investigations associated with their deliverables supporting this task order

Similar jobs

‌
‌
‌
‌