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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.

   

Job Title:

QC Sample Coordinator I

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

24OCT2024

QC Manager

Approved By:

Summary of Objective:

This position will have responsibility for supporting activities in the QC Sample Management group, which includes use of material control procedures and specification documents, raw material sampling & inspection, participation in the coordination of testing with internal and external resources, and collection of data and material certificates for review by QA.

Position will have responsibility for handling, tracking, and management of pharmaceutical within the QC department. This role ensures that samples are properly logged, distributed, stored and disposed of in accordance with established protocols, while maintaining compliance  with regulatory requirements and quality standards.

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.·Participation in the writing and revision of cGMP documents and Material Control Procedures (MCP) to meet industry standardsAssist with reviewing MCP and results to ensure accuracy and compliance.Assist with coordinating external testingPerform 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 sitesMust 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

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.

0-3 years relevant business experienceProficient in MS Office.Must have strong attention to detail as well as ability to work in a cross-functional team environmentProfessional interpersonal skills and the ability to communicate well orally and in in writingAbility to multi-task in a dynamic environment with changing prioritiesAbility to work independently as well as on a team, with limited supervisory oversightMaster Control experience a pluscGMP 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

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.