QC SAMPLE COORDINATOR l

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.

JOB DESCRIPTION:

Position Title : QC Sample Coordinator I

Location: Bedford, NH

Department: Quality Control

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 I is responsible for coordinating testing and transfer of samples both internally within PCI and with external contract laboratories, receipt and processing of critical production and raw material samples, management of proprietary client material for use as reference standards in the QC Laboratory, and ordering & receiving chemicals for laboratory use. This position will involve review of internal and external specifications, validation protocols, contract laboratory reports, and final reconciliation / close out of materials prior to submission to QA Document Control for long term filing. Additionally, this position will conduct dimensional testing of incoming container and closure samples with the use of calibrated instrumentation to support raw material release.

This position includes work in the laboratory, requiring the use of PPE, including gloves, lab coat, safety glasses.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Ordering, receipt and management of QC Laboratory supplies, including chemicals and consumable materials in accordance with cGMP and procedural requirements.

• Monitoring, ordering and maintenance of the primary QC laboratory supply KANBAN system.

• Receipt of reference standards from internal teams, clients and external suppliers, including review of documentation to meet internal requirements.

• 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.

• Request, assemble, and distribute QC testing data packets for support of in-process, lot release, raw material, and stability testing.

• 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 dimensional inspections on containers and closures materials in quarantine.

• Assist with sampling container and closure materials as needed.

QUALIFICATIONS:

Required:

• 1-3 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

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

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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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled