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Job Title:

QC Sample Coordinator II

Location:

Bedford, NH

Business Type:

Manufacturing

Department/Function:

Quality Control / Incoming materials and samples coordinator

Reports to:

QC Supervisor, Sample Management

FLSA Status:

Prepared By:

David Clater

03OCT2024

QC Manager

Approved By:

Summary of Objective:

This position will have responsibility for supporting activities in the QC Sample Management group. QC Sample Management is highly integrated with the operational activities of the site. A high level of proficiency and accuracy is expected of every QCSM coordinator. Primary activities include authoring and reviewing material control procedures (MCPs) and specification documents, raw material sampling, coordinating testing with internal and external resources, collation of data and certificates of analysis for review by QA. Success of the QC Sample Management team is critical to the success of the overall operations of the site.

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.

· Schedule and perform sampling of raw materials across the PCI NH sites and complete all applicable sample submission paperwork to the appropriate testing labs.

• Inspection, sampling and testing coordination of incoming components and raw materials, including chemicals, biologics and packaging / labeling materials in accordance with cGMP and procedural requirements

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

• Maintain sample tracking and chain of custody records in accordance with cGMP and procedural requirements

· Write and revise cGMP documents and Material Control Procedures (MCP) to meet industry standards

• Assist with reviewing MCP data and results to ensure accuracy and compliance.

• Assist with coordinating external testing

• Request and maintain Quality Control logbooks in accordance with cGMP and procedural requirements

• Perform inspections on packaging components

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 in safety cabinets while wearing PPE.

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.

• Office

• Laboratory

• Manufacturing

• Warehouse

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 2-4 years relevant business experience

• High school diploma or equivalent required

• Experience with cGMP regulated industry preferred

• Experience with QC testing laboratory or Raw Materials testing 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 experience a plus

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.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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, Diversity, Equity, and Inclusion (DEI) 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