QC Sample Coordinator II

PCI Pharma Services•Madison, WI

7d•Onsite

About The Position

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.

Requirements

2-5 years relevant business experience
Proficient in MS Office.
Must have strong attention to detail as well as 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

Nice To Haves

Master Control experience a plus
cGMP experience a plus

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 competition, 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