QC SAMPLE COORDINATOR l

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

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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.

Quality Control Sample Coordinator

Summary of Objective:

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: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

· 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.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to walk and drive between local sites

• Must be able to physically wear laboratory protective attire and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves

• Must be comfortable working with and handling hazardous materials

• Must be able to climb stairways and use stepstools

• Must be able to lift and move boxes weighing 40lbs

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Laboratory, office, warehouse

Qualifications:

• 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

• 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.