What You Will Achieve

The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, validation, and stability.  Key responsibilities are performing GMP tasks/activities associated with maintaining compliant Quality Control; managing the GMP compliance of QC instruments/equipment; creating, reviewing, executing activates for, and approving documentation; participating in investigations of events results; acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations.   

The individual should be considered able to demonstrate the following: 

• acting safely, knows and follows all EH&S safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely 

• recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pfizer policy and standards   

• excellent effective written and verbal communication and interpersonal skills; established relationships within business lines 

• ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve of issues  

• applies discipline’s principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals 

• solving highly complex mathematical problems and situation dependent problems using convoluted information  

• method 1, yellow belt trained and can apply tools to solve issues (including technical issues) 

• ability to receive feedback from management and other colleagues, takes accountability for actions and personal development 

• consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail oriented behavior 

• good judgment and correct decision making based on Pfizer procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations; decision impact awareness on future quality and compliance as well as impact on own work group, department, and network 

• represents Quality Control on site and network teams/forums that support sustaining or improving site or network operations; influences and negotiates with business lines and shares information obtained with team; acts as change agent for improvements 

• proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule  

• delivery on high business impact projects/activities/changes  

• able to holistically review and authorize all laboratory data, and have an extensive overall knowledge of all laboratory operations 

• able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records; assist with protocol non-conformance evaluations 

• able to identify and seek out external resources (e.g. PDA, ISPE) to build or enhance understanding of scientific discipline; supports training of staff; mentoring and coaching junior colleagues 

• displays strong investigative or technological orientation with independence for design of projects/studies and able to make significant independent contributions to the development of methodology including new technologies and automation 

• expertise with investigations quality system and able to independently handle complex investigations and associated CAPA within own work area under limited guidance 

• capability of detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes 

How You Will Achieve It

• Responsible for knowing, understanding and acting in accordance with Pfizer’s values and our OWNIT culture 
• Performs tasks associated with maintaining cGMP compliant Quality Control and Stability laboratories.  
•  Responsible for initiating QTS records related to change management to existing analytical equipment and any new analytical equipment enrollments. 
• Leading projects ensuring all milestones are met. 
• Escorting vendors for routine analytical equipment maintenance; ensuring vendor training and company qualifications are up to date. 
• Responsible for appropriate creation, review, approval and final authorization of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values. 
• Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS results and participating in associated laboratory investigations, reporting instrument issues and assisting with troubleshooting, etc.)  
• Responsible for contributing to and/or handle laboratory investigations for events and OOS results. 
• Trains junior colleagues and may develop training plans and/or oversee training activities for groups. 
• Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation. 
• May initiate, lead a working group and/or manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines  

Qualifications

Must-Have

• Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience. 

• Experienced and proficient with various laboratory instrumentation/equipment and validation/qualification principles. 

• Knowledgeable/experience of change control practices and quality risk management (QRM) concepts. 

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.  
Work Location Assignment: On Premise

Last Date to Apply for Job: March 30, 2023

Relocation assistance may be available based on business needs and/or eligibility.