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This position will have responsibility for supporting activities in the QC Sample Management group, which includes use of material control procedures and specification documents, raw material sampling & inspection, participation in the coordination of testing with internal and external resources, and collection of data and material certificates for review by QA.
Job Responsibility:
Review all incoming material receipt packets to assess testing needs
Schedule and perform sampling of raw materials across the PCI Madison, WI Sites
Request quotes and purchase orders for testing performed externally
Assist with regular communications with 3rd party labs performing external testing
Complete and submit all applicable sample submission paperwork to the appropriate testing labs
Escalate testing failure or safety concerns to management in a timely fashion
Assist in deviation, out-of-specification or aberrant result investigations, as needed
Assist with the writing and revision of cGMP documents and Raw Material Specifications documents to meet industry standards
Assist with reviewing testing results to ensure accuracy and compliance
Perform routine cleaning of sampling facilities
Routinely perform aseptic sampling inside a Biological Safety Cabinet
Perform dimensional inspections on packaging components
Perform routine data generation and problem solving
Order/restock laboratory and office supplies, as needed
Complete assigned training in a timely fashion
Requirements:
0-3 years relevant business experience
Proficient in MS Office
Must have strong attention to detail
Ability to work in a cross-functional team environment
Professional interpersonal skills
Ability to communicate well orally and in writing
Ability to multi-task in a dynamic environment with changing priorities
Ability to work independently as well as on a team, with limited supervisory oversight
Must be able to walk and drive between local sites
Must be able to physically wear laboratory protective attire and equipment
Must be comfortable working with and handling hazardous materials in safety cabinets