QC Sample Coordinator II: Aseptic Sampling & Materials Control

pciservices; Madison (WI); On-site; USD 28,000 - 39,000; Full time

Job summary

PCI Pharma Services in Madison, WI, is seeking a QC Sample Coordinator II to join our Quality Control team. You will coordinate sampling of raw materials, review material receipt packets, and help ensure testing and documentation meet cGMP standards.

Responsibilities include scheduling material sampling, coordinating external testing, maintaining data and certificates, and assisting with CAPA and audits as needed.

Qualifications

• 2–5 years relevant business experience.
• Must have 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.

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.

Skills

2-5 years exp

Attention to detail

Cross-functional teamwork

Communication skills

Multi-tasking

Independent working

cGMP experience

Master Control experience

Tools

MS Office

Job description

PCI Pharma Services in Madison, WI, is seeking a QC Sample Coordinator II to join our Quality Control team. You will coordinate sampling of raw materials, review material receipt packets, and help ensure testing and documentation meet cGMP standards.

Responsibilities include scheduling material sampling, coordinating external testing, maintaining data and certificates, and assisting with CAPA and audits as needed.