QC Sample Coordinator II

PCI Pharma Services; Bedford (NH); On-site; USD 55,000 - 75,000; Full time

Job summary

PCI Pharma Services is seeking a QC Sample Coordinator II in Bedford, NH. The role involves supporting the QC Sample Management group, handling sample receipt for in-process, final, raw materials, and client samples, and coordinating testing with external labs.

It also covers dimensional testing of containers and management of laboratory reference standards. Responsibilities include data entry, document review, and ensuring materials meet cGMP requirements for production release.

Qualifications

• 2-4 years of relevant 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 environment.
• Professional interpersonal skills and written communication ability.
• Ability to multi-task in a dynamic environment with changing priorities.
• Ability to work independently as well as on a team.
• Experience in aseptic handling of materials.
• Master Control or validated document system experience 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 updated materials and documentation.
• Inspect, review and receipt incoming samples for testing in QC lab or contract labs.
• Verify information against specifications and documentation to ensure accurate material receipt and compliance.
• Maintain sample tracking and chain of custody records per cGMP and SOPs.
• Complete data entry in validated systems and business tools with high accuracy.
• Coordinate testing with external contract laboratories; request quotes and POs as needed.
• Provide samples to materials management for shipment processing.
• Review and reconcile testing packets before QA submission and long-term storage.
• Request and maintain QC logbooks per cGMP and procedures.
• Perform sampling and dimensional inspections on container materials.
• Perform aseptic sampling on critical production materials.
• Ensure safe operating procedures including nitrogen overlay and biosafety cabinet use.
• Review client docs and test results to ensure cGMP compliance.
• Approve materials and test results for QA release.

Skills

Attention to detail

Cross-functional teamwork

Effective communication

Independent work

Aseptic handling

Education

High school diploma

Associate or Bachelor's in Biology/Chemistry/Microbiology

Tools

MS Office

Master Control

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Position Title: QC Sample Coordinator II

Location: Bedford, New Hampshire

Department: Quality Control / Incoming materials

Reporting To: QC Supervisor, Sample Management

Responsible For (Staff): No

This position will have responsibility for supporting activities in the QC Sample Management group. The coordinator II is responsible for QC tasks supporting the laboratory group, including sample receipt of in process, final product, raw material, validation and client samples as well as management of laboratory reference standards. This position also supports work on incoming raw materials by coordinating testing with external contract laboratories and performing aseptic sampling utilizing appropriate materials and following applicable material specifications and SOPs. This position will involve reviewing internal and external specifications, validation protocols, contract laboratory reports, and final reconciliation / close out of materials prior to submission to QA for review. Additionally, this position will conduct dimensional testing of incoming containers and closure samples with the use of calibrated instrumentation to support raw material release.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Management of the reference standard inventory, including communication with internal project management teams to request additional client supplied materials and updated documentation for materials currently in inventory.
• Inspection, review and receipt of incoming samples for testing in the QC laboratory and/or contract laboratories.
• Verification of information against specifications, protocols and other documentation to ensure accurate material receipt and compliance.
• Maintain sample tracking and chain of custody records in accordance with cGMP and procedural requirements.
• Complete data entry in validated systems and business tools with a high degree of accuracy.
• Coordinating testing with external contract laboratories. Request quotes and POs as needed, and coordinate with project management for client managed testing.
• Provide documentation and samples to the materials management team to process for shipment.
• Review and reconcile completed testing packets prior to submission to QA Document Control for long term storage.
• Request and maintain Quality Control logbooks in accordance with cGMP and procedural requirements
• Perform sampling and dimensional inspections on container and closure materials.
• Perform aseptic sampling on critical production materials including active ingredients, bulk drug substances, excipients.
• Sample materials following the outlined instructions in specifications and SOPs ensuring that there is no impact to the bulk material or contamination of test samples.
• Operate safely while handling materials including performing sampling under nitrogen overlay and in the biological safety cabinet.
• Review client documentation and test results with a high degree of accuracy to ensure that materials meet all cGMP requirements for use in production.
• Approve materials and test results for submission to QA for release.

QUALIFICATIONS:

Required:

• 2-4 years relevant business experience or education
• High school diploma required; Associate's or Bachelor's degree in a scientific discipline (Biology, Chemistry, Microbiology, or related field) preferred.
• 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
• Experience in aseptic handling of materials
• Master Control or equivalent experience working with a validated document system preferred
• Basic understanding of cGMP, GDP, and laboratory workflows preferred
• Laboratory experience and familiarity with chemical handling preferred

Preferred:

• Master Control or equivalent experience working with a validated document system preferred
• Basic understanding of cGMP, GDP, and laboratory workflows preferred
• Laboratory experience and familiarity with chemical handling preferred

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.