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We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
Perform analytical method transfers, validations, verifications and testing using multiple techniques (HPLC, GC, ICP-MS, etc.). Interpret data, maintain GMP/GLP documentation, revise SOPs, support process validation and troubleshooting, manage CAPA/change control, and coordinate cross-functional activities under supervisor direction.
Summary Generated by Built In
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. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you 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.
What You Will Achieve
In this role, you will:
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Work Location Assignment: On Premise
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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 .
Quality Assurance and Control
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. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you 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.
What You Will Achieve
In this role, you will:
- Perform method transfers/ validations / method verifications to the complex analytical techniques
- Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.
- Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.
- Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.
- Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database.
- Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.
Here Is What You Need (Minimum Requirements)
- Master's degree in chemistry/ pharmacy with 8-10 years of experience in Analytical Method Transfer / Validation)
- Qualified in multiple analytical techniques (HPLC-with Empower, GC, IC, ICP-MS, Potentiometry, UV‑Vis, FTIR, Karl Fischer, and pH meters)
- Demonstrated technical skills in method validation and testing
- Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
- Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards, encompassing protocol preparation, execution, approval of validation summaries, and coordination with cross‑functional teams.
- Conduct test method GAP assessments against USP, EP, BP, and JP requirements for New Product Introduction (NPI).
- Execute and document analytical method verification and method transfer activities.
- Demonstrate knowledge of ICH Q9 (Quality Risk Management) and apply risk‑based principles for identifying, assessing, controlling, communicating, and reviewing quality risks throughout the product lifecycle.
- Perform identification, assay, purity, and related analytical tests using validated methods.
- Monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
- Support process validation and troubleshooting activities; communicate analytical results promptly to Production and QA to ensure effective process control.
- Manage working standards in compliance with established procedures.
- Handle change control activities and ensure timely implementation and closure of related CAPA actions.
- Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.
- Excellent organizational skills and strong ability to multi-task
- Strong written and verbal communication skills
- Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation
Bonus Points If You Have (Preferred Requirements)
- Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography),GC,IC, ICP-MS techniques
- Proven track record in leading continuous improvement projects
- Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis
- Strong problem-solving skills and attention to detail
- Ability to manage multiple priorities and meet deadlines.
- Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels
- Adaptability and willingness to learn new techniques and procedures
Work Location Assignment: On Premise
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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 .
Quality Assurance and Control
Skills Required
- Master's degree in chemistry or pharmacy with 8-10 years experience in Analytical Method Transfer/Validation
- Qualified in multiple analytical techniques: HPLC (with Empower), GC, IC, ICP-MS, Potentiometry, UV-Vis, FTIR, Karl Fischer, pH meters
- Demonstrated technical skills in method validation and testing
- Ability to read and understand compendial methods, SOPs, technical procedures, and governmental regulations
- Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards, including protocol preparation and validation summaries
- Conduct test method GAP assessments against USP, EP, BP, and JP for New Product Introduction (NPI)
- Execute and document analytical method verification and method transfer activities
- Knowledge and application of ICH Q9 (Quality Risk Management) principles
- Perform identification, assay, purity and related analytical tests using validated methods
- Monitor critical process parameters (CPPs) and critical quality attributes (CQAs)
- Support process validation and troubleshooting; communicate analytical results to Production and QA
- Manage working standards in compliance with established procedures
- Handle change control activities and ensure timely implementation and closure of related CAPA actions
- Knowledge of Good Manufacturing Practices and application of GMP standards, processes, and policies
- Excellent organizational skills and strong ability to multi-task
- Strong written and verbal communication skills
- Proficiency with Quality Control instruments for sample management, retains management, interpretation, and evaluation
What the Team is Saying
Daniel
Diagnostics Launch Lead
Anna
R&D Privacy Steward
Esteban
Specialist
Pfizer
Pfizer Compensation & Benefits Highlights
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Healthcare Strength — Multiple U.S. medical plan options include telehealth, comprehensive mental‑health support, fertility/family‑building benefits, transgender‑inclusive coverage, and certain Pfizer medications at no cost. A Wellbeing Wallet and wellness resources broaden the health and wellbeing offering.
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Retirement Support — A 401(k) with company matching is paired with an additional Pfizer Retirement Savings Contribution, alongside company‑paid life and disability insurance. One‑on‑one financial planning support is provided through Fidelity.
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Leave & Time Off Breadth — Paid time off spans vacation, holidays, and personal days, with additional caregiver and medical leave. U.S. parental leave commonly includes 12 weeks paid with options for additional unpaid bonding time and a return‑to‑work transition.
Pfizer Insights
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The Company
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
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