QC Senior Scientist - Analytical

USE YOUR POWER FOR PURPOSE

At Pfizer, our purpose is to deliver breakthroughs that change patients' lives. Central to this mission is our Research and Development team, which strives to translate advanced science and innovative technologies into impactful therapies and vaccines. Whether you are involved in discovery sciences, ensuring drug safety and efficacy, or supporting clinical trials, your role is crucial. You will leverage cutting-edge design and process development capabilities to accelerate the delivery of best-in-class medicines to patients globally.

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 and Stability laboratories; analyzing, interpreting, and trending results/data; creating, reviewing, executing activates for, and approving documentation; participating in and/or leading investigations of events/OOS results; designing, organizing, and/or conducting  assay development/automation/troubleshooting/method transfer/validation activities, acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations; represents and makes decisions for Quality Control on cross functional teams; leads projects and/or teams providing guidance/training/coaching to junior colleagues; and conducting project management for site and network projects. 

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 Subject Matter Expert having extensive technical knowledge of assays and instrumentation used within QC.
• Reliable to support audits and to expertly review/approve technical content ensuring both scientific merit and compliance to regulatory agency 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 take leadership role to resolve or independently  resolves complex issues.
• Applies discipline’s principles, appropriate procedures, and leadership skills to develop action plans and contributes to executing toward individual, team, and project goals.
• Expertly solving highly complex mathematical problems and solving situation dependent multifaceted problems using even only ambiguous information.
• At least method 1, yellow belt certified and/or applies method 1 tools to solve complex issues, implements unique approaches to problem solving, and may coach others to become method 1 certified.
• Receives feedback well from management and other colleagues, grows self-utilizing feedback and takes accountability for actions and personal development.
• Collaborate/independently engage with a wide range of co-workers, customers and management within the Network to gather the input and background knowledge needed to complete assignments.
• Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail-oriented behavior.
• Good judgment and correct decision making based on expert knowledge of Pfizer procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations.
• Decision making that includes impact awareness on future quality and compliance as well as impact on own work group, department, and site.
• Represents Quality Control on site and network teams/forums/summits that support sustaining or improving site or network operations; influences and negotiating with business lines and shares information obtained with Quality Operations.
• Influential change agent fostering continuous improvement behaviors in others.
• Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, team, department, or Network goal/deliverable is off schedule.
• Delivery on large and complex 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 design/create, organize execution, 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 orenhance understanding of scientific discipline; actively supports training of staff; understands the importance of mentors and coaches junior colleagues; seeks mentor for self.
• Displays strong investigative or technological orientation with independence for design of projects/studies and makes significant independent contributions to the development/improvement/trouble shooting of methodology including new technologies and automation.
• Expertise with the investigations quality system and able to independently handle complex investigations and determine associated CAPA with no guidance.

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 and Stability laboratories; analyzing, interpreting, and trending results/data; creating, reviewing, executing activates for, and approving documentation; participating in and/or leading investigations of events/OOS results; designing, organizing, and/or conducting  assay development/automation/troubleshooting/method transfer/validation activities, acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations; represents and makes decisions for Quality Control on cross functional teams; leads projects and/or teams providing guidance/training/coaching to junior colleagues; and conducting project management for site and network projects. 

Individual should have knowledge and be technically competent of US, EU, and ROW cGMP; pharmacopeias; ICH guidelines; analytical techniques and instrumentation, Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM  application); Microsoft Office™ applications specifically Word, Excel, and PowerPoint; statistical software such as JMPTM and MinitabTM; Lean Six Sigma concepts; Lean Labs; project management tools including stakeholder management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.

Responsible for knowing, understanding and acting in accordance with Pfizer’s values and our OWNIT culture.

Perform tasks associated with maintaining and improving cGMP compliant Quality Control and/or Stability laboratories.

• May perform testing including but not limited to clinical and/or commercial product, raw materials, validation, and stability samples.
• 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.
• Analyzes and interprets QC results, makes decisions regarding accuracy, completeness and compliance; performs data trending; evaluates trending reports and influences / agrees actions with key stakeholders. 
• Responsible for appropriate design, review, approval and final authorization of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process technology transfer activities, documents for regulatory filings, regulatory filings, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values.
• Responsible for detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes.
• Responsible for significantly contributing to and/or leading laboratory investigations into events and OOS results.  Evaluates and approves the best CAPA for root cause to eliminate repeat events.
• Responsible for reporting issues to management and leading issue resolution or independently resolving issues (such as reporting OOS results, participating in/leading associated laboratory investigations, reporting instrument issues and assisting with/conducting/leading troubleshooting activities, etc.).
• Responsible for initiating, leading a working group and/or manage projects/changes to accomplish change activities/project deliverables and whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines.
• Responsible for improving and automating existing and developing methodologies and new technologies.
• Serves on cross functional teams to represent Quality Operations and facilitate communications and activities/projects between Quality Operations and site departments and/or Network.  Serves as technical SME for the QO in these interactions and makes decisions on Quality Operations behalf.
• May manage a business system (e.g. manages LIMS system, stability system) or product from the Quality Organization perspective.

HERE IS WHAT YOU NEED (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience 
• Manufacturing, quality or laboratory experience in the biotech or pharmaceutical industry.
• Experienced and technically competent (SME) with laboratory practices, analytical testing, and use of analytical equipment: i.e. UV-VIS, HPLC, UPLC, pH, appearance, osmolality, TOC and conductivity, and various other instruments.
  

BONUS POINTS IF YOU HAVE (Preferred Requirements)

• Proficiency in analytical techniques, particularly LC-MS.
• Solid understanding of separation technologies such as liquid chromatography.
• Strong problem-solving skills and the ability to make decisions to resolve moderately complex problems.
• Experience in 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.
   
  

PHYSICAL/MENTAL REQUIREMENTS

Ability to lift 30 lbs, stand or sit for 2 to 3 hours at a time, walk long distances, and bend to obtain items from lower shelving/cabinets.

Intellectual capacity to perform mathematical problems and perform data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional off-shift work required as business demands. Rotational weekend coverage.

OTHER JOB DETAILS

Work Location Assignment: On Premise

Last Date to Apply for Job: November 3, 2026

The annual base salary for this position ranges from $99,200.00 to $165,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Research and Development