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PCI Pharma Services

Pharmaceutical packaging and contract services

QC Sample Coordinator 2

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeMadison, WI, USANo salary listed

About the Job

Requirements

  • Two to five years of relevant business experience.
  • Proficiency in Microsoft Office.
  • Strong attention to detail and ability to work in a cross-functional team environment.
  • Professional interpersonal skills and ability to communicate well orally and in writing.
  • Ability to multitask in a dynamic environment with changing priorities.
  • Ability to work independently and on a team with limited supervisory oversight.
  • Ability to walk and drive between local sites.
  • Ability to wear laboratory protective attire and equipment, including gowning, goggles, face shields, respirators, and protective gloves.
  • Comfort working with and handling hazardous materials in safety cabinets.
  • Ability to safely lift more than 40 pounds.

Responsibilities

  • Support activities in the QC Sample Management group, including use of material control procedures and specification documents, raw material sampling and inspection, coordination of testing with internal and external resources, and collection of data and material certificates for QA review.
  • 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 externally performed testing.
  • Submit applicable sample submission paperwork to the appropriate testing labs.
  • Communicate regularly with third-party labs performing external testing.
  • Perform dimensional inspections on packaging components.
  • Manage shipment of all final product samples.
  • Review testing results for accuracy and compliance.
  • Perform routine data generation and problem solving.
  • Escalate testing failures 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 and 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 sampling processes.

Desired Qualifications

  • Master Control experience is a plus.
  • cGMP experience is a plus.

About the Company

PCI Pharma Services

Pharmaceutical packaging and contract services

PCI Pharma Services provides end-to-end pharmaceutical packaging and related services, including folding cartons, labels, contract packaging, clinical services, and brand protection, acting as a one-stop source for healthcare product development and commercialization. It handles packaging operations from cartons and labels to contract packaging and labeling, plus clinical packaging and brand protection, with processes built on cGMP and ISO compliance, lean manufacturing, and ongoing R&D, supported by mandatory training and strict security, hygiene, and inspections. It differentiates itself with eight decades of experience and a broad, integrated service suite under one roof, reducing risk and handoffs for clients. Its goal is to be a trusted packaging partner that delivers reliable, compliant, and scalable solutions so healthcare brands stay protected and clients can focus on their core business.

Company size
1-10
Company stage
Debt Financing
Total funding
$4B
Headquarters
Burlington, Canada
Founded
1971

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