Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. You will play a crucial role in improving patients’ lives by ensuring the highest standards of quality and safety in our products. Your leadership will be instrumental in driving innovation and excellence, ultimately making a global impact on patient health.
Supervisor of QC Sample Management will lead a team of sample coordinators in support of the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with the planning, forecasting, receipt, aliquoting, distribution and external testing lab shipment for site clinical and/or commercial products, raw materials, validation, and stability studies.
What You Will Achieve

In this role, you will:

• Manage a team responsible for receiving, aliquoting, storage, tracking, and shipment of incoming samples for QC testing (includes in process, release, stability and raw materials)
• Ensures testing labs (internal/external) have visibility to incoming sample submissions and expected testing windows.
• Supply sample receipt forecast and associated metrics to leadership and stakeholders.
• Leading the sample management process for QC (receipt from manufacturing, maintaining chain of custody in LIMS, aliquoting/delivering samples to appropriate lab, shipment to external testing sites).
• Responsible for appropriate creation, review and approval of GMP documentation (sample plans, test records, stability protocols, and as assigned reports, test methods, equipment records, etc.).
• Ensuring adherence to Pfizer standards, guidelines and values.
• Reporting issues to counterparts/ management and participating in issue resolution (such as reporting OOS result and participating in associated laboratory investigation, reporting instrument issues and assisting with troubleshooting, etc.)
• Assessing existing situations and suggesting improvements to increase compliance and innovation.
• Supports sample traceability and status metrics.
• May perform data trending activities and assist with metrics reporting.
• May initiate and develop project plans to ensure projects timely completion.
• Support management of contract testing laboratories in regard to scheduling, shipment of samples used for analytical and compendial testing.
• Provides expert review of QC data and associated documentation.
• Responsible for participating in, leading, or providing guidance for investigations related to sample management activities and responsibilities.
• Contributes to laboratory operations activities related to equipment monitoring, cleaning, and maintenance.
• Operate to the highest ethical and moral standards.
• Comply with all Pfizer policies and procedures.
• Communicate effectively with clients, colleagues and staff.
• Responsible for colleagues objective setting, conducting one on one meetings with Colleagues, providing guidance/coaching, assisting with colleague development planning, and completing performance reviews
• Determines appropriate training curriculums for colleagues

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor’s degree with at least 2 years of experience; OR a master’s degree with 0+ years of experience;

OR an associate’s degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience

• Experience in the biotech or pharmaceutical industry
• Ability to utilize email, word processing and spreadsheet software.
• Management experience (people, project, process)

Technical competencies

• Knowledge of compendia (USP, JP, EP) and ICH guidelines.
• Knowledge of GMPs, safety regulations and data integrity.
• Proficient use of LIMS systems
• Knowledge of material receipt and inventory control.
• Support training of new staff within immediate team; mentoring and coaching junior colleagues
• Experience assisting with laboratory investigations to define root cause and assisting with validation protocol non-conformances

PHYSICAL/MENTAL REQUIREMENTS

Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets
Intellectual capability to perform complex mathematical problems and perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.
Limited travel for the position; no more than 10% traveling.

• Manage a team responsible for receiving, aliquoting, storage, tracking, and shipment of incoming samples for QC testing (includes in process, release, stability and raw materials)
• Ensures testing labs (internal/external) have visibility to incoming sample submissions and expected testing windows.
• Supply sample receipt forecast and associated metrics to leadership and stakeholders.
• Leading the sample management process for QC (receipt from manufacturing, maintaining chain of custody in LIMS, aliquoting/delivering samples to appropriate lab, shipment to external testing sites).
• Responsible for appropriate creation, review and approval of GMP documentation (sample plans, test records, stability protocols, and as assigned reports, test methods, equipment records, etc.).
• Ensuring adherence to Pfizer standards, guidelines and values.
• Reporting issues to counterparts/ management and participating in issue resolution (such as reporting OOS result and participating in associated laboratory investigation, reporting instrument issues and assisting with troubleshooting, etc.)
• Assessing existing situations and suggesting improvements to increase compliance and innovation.
• Supports sample traceability and status metrics.
• May perform data trending activities and assist with metrics reporting.
• May initiate and develop project plans to ensure projects timely completion.
• Support management of contract testing laboratories in regard to scheduling, shipment of samples used for analytical and compendial testing.
• Provides expert review of QC data and associated documentation.
• Responsible for participating in, leading, or providing guidance for investigations related to sample management activities and responsibilities.
• Contributes to laboratory operations activities related to equipment monitoring, cleaning, and maintenance.
• Operate to the highest ethical and moral standards.
• Comply with all Pfizer policies and procedures.
• Communicate effectively with clients, colleagues and staff.
• Responsible for colleagues objective setting, conducting one on one meetings with Colleagues, providing guidance/coaching, assisting with colleague development planning, and completing performance reviews
• Determines appropriate training curriculums for colleague