QC Scientist, Stability

Pfizer • Sanford, NC

3d • Onsite

About The Position

At Pfizer, every day is an opportunity to make a difference in patients' lives. Your contributions will directly impact patient care, as you work within a flexible, innovative, and customer-oriented culture rooted in science and risk-based compliance. By joining our team, you will help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.

Requirements

• BA/BS with 6+ years of experience or MBA/MS with 4+ years of experience
• Experienced and proficient with laboratory practices, good knowledge of Stability, Good Manufacturing Practices (cGMP), and compliance requirements for Quality Control Laboratories.

Nice To Haves

• Strong background in leading continuous improvement projects
• Demonstrated expertise in defending laboratory practices during regulatory audits
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
• Proficiency in LIMS

Responsibilities

• Perform tasks associated with maintaining Current Good Manufacturing Practices (GxP) compliant Quality Control and Stability laboratories
• Complete activities to implement Stability protocols and studies for new products and annual stability for commercial products
• Forecasting for QC Labs expected Stability pulls and performs Stability pulls
• Complete actions for end of studies and sample disposal
• Metric tracking and reporting
• Providing investigation support and troubleshooting stability issues
• Maintenance and continuous improvement of Stability procedures and processes
• Stability regulatory submissions document creation and review
• Responsible for requesting detailed LIMS builds and LIMS Master Data changes.
• Responsible for reporting issues to management and participating in issue resolution
• Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
• Initiate, 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
• Train junior colleagues and may develop training plans and/or oversee training activities
• Represent Quality Control Analytical in cross-functional and site product meetings and provide subject matter expertise for standard operating procedures and quality standards content
• Support change controls, investigations, and other technical documents, participate in regulatory filing writing, and determine environmental monitoring locations and qualification requirements for aseptic facility modifications and new facilities

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level