QC Sample Coordinator II
PCI Pharma Services · Madison, WI · Yesterday
Quality AssuranceFull-time
Date Issued: August 5, 2026 | Application Deadline: August 12, 2025 | Wage Level: hourly
About the role
This position supports activities in the QC Sample Management group, including use of material control procedures and specification documents, raw material sampling & inspection, coordination of testing with internal and external resources, and collection of data and material certificates for review by QA.
Responsibilities
- Review incoming material receipt packets to assess testing needs
- Regularly check USP, EP, and JP Compendia for material monograph updates
- Create and revise cGMP documents and Raw Material Specifications documents per current industry standards
- Schedule sampling of raw materials
- Routinely perform aseptic sampling inside a Biological Safety Cabinet
- Perform routine cleaning of sampling facilities
- Request quotes and purchase orders for testing performed externally
- Submit all applicable sample submission paperwork to the appropriate testing labs
- Assist with regular communications with 3rd party labs performing external testing
- Perform dimensional inspections on packaging components
- Manage shipment of all final product samples
- Review testing results to ensure accuracy and compliance
- Perform routine data generation and problem solving
- Escalate testing failure or safety concerns to management in a timely manner
- Independently manage deviation, out-of-specification or aberrant result investigations, as needed
- Assist with CAPA, MOC completion, and Audit responses, as needed
- Order/restock laboratory and office supplies, as needed
- Complete assigned training in a timely fashion
- Attend scheduling meetings and communicate critical timelines or potential challenges to the pending manufacturing schedule
- Review final product and sampling plans for accuracy
- Coordinate training experiences for new hires on the sampling processes
Requirements
- 2-5 years relevant business experience
- Proficient in MS Office
- Strong attention to detail and ability to work in a cross-functional team environment
- Professional interpersonal skills and the 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
- Master Control experience a plus
- cGMP experience a plus
Special Demands
- Must be able to walk and drive between local sites
- Must be able to physically wear laboratory protective attire and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
- Must be comfortable working with and handling hazardous materials in safety cabinets
- Must be able to safely lift 40+ lbs