QC Sample Coordinator II: Aseptic & Material Testing

pciservices

Bedford (NH)

On-site

USD 48,000 - 62,000

Full time

5 days ago
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Job summary

PCI Pharma Services in Bedford, NH is seeking a QC Sample Coordinator II to support the QC Sample Management group. The role covers sample receipt, testing coordination with contract labs, and documentation in validated systems to ensure compliant material release.

The position emphasizes aseptic sampling, material specifications review, and maintaining chain of custody. A science background, strong detail orientation, and teamwork are essential for success in this role.

Qualifications

  • 2-4 years relevant business experience or education
  • High school diploma required; Associate's or Bachelor's degree in a scientific discipline preferred
  • Proficient in MS Office
  • Strong attention to detail and ability to work in a cross-functional team
  • Professional interpersonal skills and written/verbal communication
  • Ability to multi-task in a dynamic environment with changing priorities
  • Ability to work independently as well as on a team with limited supervision
  • Experience in aseptic handling of materials
  • Master Control or equivalent experience with a validated document system preferred
  • Basic understanding of cGMP, GDP, and laboratory workflows preferred
  • Laboratory experience and familiarity with chemical handling preferred

Responsibilities

  • Manage the reference standard inventory and coordinate with internal teams for additional client materials and documentation
  • Inspect, review and receipt incoming samples for testing in QC labs or contract laboratories
  • Verify information against specifications and documentation for accurate material receipt and compliance
  • Maintain sample tracking and chain of custody records per cGMP and procedures
  • Complete data entry in validated systems with high accuracy
  • Coordinate testing with external contract laboratories and request quotes and POs as needed
  • Provide documentation and samples to materials management for shipment
  • Review and reconcile testing packets before submission to QA for long-term storage
  • Perform sampling and dimensional inspections on containers and closures
  • Perform aseptic sampling on production materials including active ingredients and excipients
  • Ensure sampling follows SOPs and does not contaminate materials
  • Operate safely when handling materials, including nitrogen overlay and BSC use
  • Review client documentation and test results to ensure materials meet cGMP requirements for production
  • Approve materials and test results for submission to QA for release

Skills

MS Office proficiency
Attention to detail
Strong communication skills
Team collaboration
Multitasking

Education

Associate's degree in science
Bachelor's degree in science (preferred)
High school diploma required

Tools

Master Control (validated document system)

Job description

PCI Pharma Services in Bedford, NH is seeking a QC Sample Coordinator II to support the QC Sample Management group. The role covers sample receipt, testing coordination with contract labs, and documentation in validated systems to ensure compliant material release.

The position emphasizes aseptic sampling, material specifications review, and maintaining chain of custody. A science background, strong detail orientation, and teamwork are essential for success in this role.

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