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 Title: Supervisor, QC Sample Management Location: Bedford, NH Summary of Objective: The Supervisor of QC Sample Management is responsible for the supervision of all day-to-day activities in support of the sample management program for Quality Control. This role requires a high level of customer service, collaboration and cross functional support for manufacturing operations at our Harvey and Commerce Facilities, including interactions with external customers and vendors. The incumbent is expected to be an innovative leader with experience in fast-paced Quality Control testing environments. The supervisor will provide training and guidance to ensure high performance and compliance with cGMP procedures. Essential Duties and Responsibilities: Supervisory Supervise and mentor a team of 3-5 QC Sample Management direct reports to implement the end-to-end process of sample receipt, storage, and distribution, ensuring accuracy and adherence to regulatory requirements. Act as a ‘working supervisor’, participating in all activities of the QCSM team, as identified below in Sample Management duties. Manage the Specification documents (MCP’s) for the site, which are mission-critical for the entire operation. Actively partner with Quality Control Analytical & Microbiology, Project Management, Operations, Materials Management and Quality Assurance to ensure completion of activities and adherence to production schedules . Author and revise technical documentation such as SOPs, specifications, and forms as required. Perform continuous improvement for areas of responsibility, collaborating with other departments to identify and implement process efficiencies. Sample Management: Responsible for the supervision of QC test samples including receipt, storage, and distribution of samples to internal and external testing labs in accordance with required turnaround times. Maintain sample tracking and chain of custody records in accordance with cGMP and procedural requirements. Responsible for QC inspection, sampling and testing coordination of incoming components and raw materials, including chemicals, biologicals 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 Quality Control testing source data packets and perform data archival as required. Requests and maintain Quality Control logbooks in accordance with cGMP and procedural requirements. Responsible for authoring and revising raw material specifications (MCP’s) as required. Responsible for the management and storage of reference standards including management of certificates, expiration tracking, ordering replacement material and sourcing alternate supply when necessary. Responsible for inventory management of all QC laboratory supplies including reagents, media, consumables, etc. Ensure that all laboratory samples are appropriately labelled and stored per procedural requirements. Ensure that obsoleted and expired samples and materials are disposed of in accordance with procedural requirements. Respond to QC equipment alarms and ensure appropriate resolution. Contribute to investigations and deviations related to QC sample management Perform data review as required. Prepare reports on sample inventory, usage and distribution metrics for management review, utilizing data to inform strategic decisions. Represent the Sample Management group in onsite client audits by providing tours, data as requested, and sitting for interviews. PROFESSIONAL SKILLS Excellent written and verbal communication skills. Effective time management, multitasking and organizational skills with the capability to manage multiple priorities concurrently. Strong attention to detail and cross functional team experience. Ability to work independently and in compliance with cGMPs. Proficiency with computer systems such as Microsoft Office applications 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 Must have hand dexterity and visual acuity sufficient to utilize a caliper and small ruler Qualifications: Minimum of 5 years of experience in the biotechnology or pharma industry with a strong familiarity with raw materials and/or sample management of regulated products required Attained Bachelor’s or associate degree in relevant field (e.g. Chemistry, ChemE, Analytical Chemistry, etc.) preferred. 2+ years of supervisory experience in a laboratory environment preferred. Three to 5 years of established background in analytical/technical cGMP experience required. Experience with vendor management of Contract Manufacturing Organizations and/or Contract Testing Labs is preferred. Experience with ICH guidelines, USP/EP raw material testing of pharmaceutical products 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. #LI-AK1 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. 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.