Conducts procedure updates in QC lab and GMP reviews of logbooks
Coordinates waste management, LEAN and 5S efforts as required.
Performs final product release testing including those tests applicable for endotoxin, sterility, and toxicity.
Performs raw material release testing including microbial limits, endotoxin, and potency where required.
Performs testing, analyzing, and submits results so that commercial manufacturing activities are not impacted.
Assists in laboratory method and/or instrumentation validation activities.
Coordinates routine monitoring and validation activities.
Orders supplies and assigns expiry to incoming materials, tracks requisitions and reconciles against incoming materials and invoices.
Performs microbiological testing of raw material, in process, final product, validation-related, and critical utility samples.
Performs bioburden testing of water and product.
Performs environmental monitoring including surface viable air, non-viable air and personnel monitoring.
Performs endotoxin testing using kinetic chromogenic methodology.
Performs critical utility monitoring as required.
Proficiency in general Microbiology techniques such as gram staining; analyze filtration testing, microbial identification, aseptic technique, and plate streaking technique.
Working knowledge of GMPs, pharmacopoeial, and regulatory requirements for testing and validation.
Advanced knowledge of current Good Manufacturing Practices (GMPs).
Instrumentation skills.
Detail orientation and problem solving skills.
Organizational skills and common sense.
