QC Senior Scientist - Analytical

Pfizer • Sanford, NC

3d • Onsite

About The Position

The QC Senior Scientist - Analytical supports Pfizer’s Sanford, North Carolina Quality Operations department by performing Quality Control activities for clinical and/or commercial products, raw materials, validation, and stability. The role maintains and improves compliant Quality Control and Stability laboratories, analyzes and trends data, reviews and approves GMP documentation, and contributes to or leads laboratory investigations, including investigations of events and out-of-specification results. The position also designs and conducts assay development, automation, troubleshooting, method transfer, and validation activities; drives continuous improvement and innovative implementations; and represents Quality Control on cross-functional site and network teams. The role leads projects and teams, coaches and trains junior colleagues, and manages site and network project deliverables.

The successful candidate serves as a technical subject matter expert with extensive knowledge of laboratory assays, instrumentation, and operations. They review and authorize laboratory data and technical documentation for scientific merit and compliance with regulatory requirements and Pfizer standards. The position requires sound decisions, independent resolution of complex issues, effective investigation and CAPA work, and the ability to influence stakeholders and lead changes that improve quality, compliance, and laboratory operations. The role may also manage a Quality organization business system or product, such as LIMS or a stability system.

The position is on premise. Occasional off-shift work and rotational weekend coverage are required as business demands. The role includes physical activities such as lifting up to 30 pounds, standing or sitting for two to three hours at a time, walking long distances, and bending to reach lower shelving or cabinets. The job requires mathematical problem-solving and data analysis.

Requirements

• A bachelor's degree and at least 4 years of experience; or a master's degree and at least 2 years; or a Ph.D. and 0 or more years; or an associate degree and 8 years; or a high school diploma or equivalent and 10 years of relevant experience.
• Manufacturing, quality, or laboratory experience in the biotechnology or pharmaceutical industry.
• Technical competence with laboratory practices, analytical testing, and analytical equipment, including instruments such as UV-VIS, HPLC, UPLC, pH, appearance, osmolality, TOC, and conductivity.
• Knowledge of US, EU, and rest-of-world cGMP requirements, pharmacopeias, ICH guidelines, and applicable regulatory requirements.
• Knowledge of analytical techniques and instrumentation, laboratory operations, and laboratory information management systems.
• Knowledge of quality tracking systems such as TrackWise and Microsoft Office applications, including Word, Excel, and PowerPoint.
• Knowledge of statistical software such as JMP and Minitab, Lean Six Sigma concepts, Lean Labs, project management, stakeholder management, quality change control, investigations, documentation systems, and Quality Risk Management and risk assessments.
• Ability to independently handle complex investigations and determine CAPAs, review and authorize laboratory data, and make sound quality and compliance decisions.
• Strong written and verbal communication, interpersonal, collaboration, leadership, problem-solving, and decision-making skills.
• Attention to detail and accuracy, with the ability to manage complex work and contribute to individual, team, and project goals.
• At least Method 1 Yellow Belt certification and/or use of Method 1 tools to solve complex issues; may coach others toward certification.
• Ability to lift 30 pounds, stand or sit for 2 to 3 hours at a time, walk long distances, and bend to retrieve items from lower shelving or cabinets.
• Ability to perform mathematical problems and data analysis.
• Authorization to work in the United States; work visa sponsorship is not available for this role.
• Permanent work authorization in the United States is required.

Nice To Haves

• Proficiency in analytical techniques, particularly LC-MS.
• Solid understanding of separation technologies such as liquid chromatography.
• Strong problem-solving skills and ability to make decisions to resolve moderately complex problems.
• Experience mentoring and guiding team members.
• Ability to work collaboratively in a team environment.
• Strong attention to detail and accuracy.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem-solving and enhance work.

Responsibilities

• Perform GMP activities to maintain and improve compliant Quality Control and/or Stability laboratories.
• Perform testing, as applicable, on clinical and/or commercial products, raw materials, validation samples, and stability samples.
• Analyze, interpret, and trend QC results; assess accuracy, completeness, and compliance; evaluate trends and agree on actions with stakeholders.
• Design, review, approve, and authorize GMP documentation, including test records, validation and method-transfer protocols and reports, test methods, equipment records, technology-transfer activities, and regulatory filing documents.
• Detail requirements for LIMS builds and/or build and test LIMS changes and master data.
• Contribute to or lead laboratory investigations into events and out-of-specification results, determine root causes, and evaluate and approve effective CAPAs.
• Report issues to management and lead or independently resolve issues, including instrument troubleshooting and laboratory investigation activities.
• Initiate and lead working groups, projects, and changes; prioritize work and deliver activities and project timelines on schedule.
• Improve and automate existing methodologies and develop new methodologies and technologies.
• Represent Quality Operations on cross-functional site and network teams, facilitate communication and project activities, and make decisions as a Quality Operations technical subject matter expert.
• Lead projects and teams and provide guidance, training, and coaching to junior colleagues; develop training plans or oversee group training as needed.
• Assess laboratory situations and recommend continuous improvements that increase compliance and innovation.
• Support audits and review or approve technical content for scientific merit and regulatory and company compliance.
• Apply safety requirements, lead safety initiatives, and encourage safe practices in QC laboratories.
• Manage a Quality organization business system or product, where assigned, such as LIMS or a stability system.
• Manage site and network project activities and deliverables, using project management and stakeholder management practices.

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.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility for Pfizer’s Global Performance Plan, with a 12.5% bonus target of base salary.
• Eligibility to participate in a share-based long-term incentive program.
• Relocation assistance may be available based on business needs and eligibility.
• Comprehensive benefits and programs intended to support colleagues’ health and life needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED