Pfizer
Healthcare
QCChemist(AS&T)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“QC Chemist (AS&T) at Pfizer. Skills: Analytical method transfer, Method validation, Analytical testing, Good Manufacturing Practices, Good Laboratory Practices. Perform analytical method transfer. Perform method validation”
Industry & Context.
Problem solving; Root cause analysis; Troubleshooting
What They're Looking For.
Must Have
Bachelor's degree with two years of experience, Associate's degree with 4 years of experience, High school diploma and 6 years of experience, Demonstrated technical skills in method transfer, Demonstrated technical skills in method validation, Demonstrated technical skills in method verification, Demonstrated technical skills in testing, Ability to read compendial methods, Ability to read Standard Operating Procedures, Ability to read technical procedures, Ability to read governmental regulations, Knowledge of Good Manufacturing Practices, Excellent organizational skills, Ability to multi-task, Compliance to GMP/GLP, Compliance to Pfizer Quality Standards, Understand Data Integrity requirements, Understand Good Documentation Practices, Perform test method validation, Perform cleaning method validation, Update SOPs to align with PQS, Update SOPs to align with regulatory requirement, Proficiency with Quality Control instruments
Nice to Have
Experience with laboratory work, Experience using analytical HPLC, Proven track record in leading continuous improvement projects, Knowledge of lean manufacturing principles, Knowledge of six sigma methodologies, Knowledge of statistical analysis, Ability to manage multiple priorities, Ability to meet deadlines, Adaptability, Willingness to learn new techniques, Willingness to learn new procedures, Experience using common AI tools, Experience using generative technologies, Demonstrated curiosity for AI tools, Understanding of responsible AI practices
What You'll Do.
Perform analytical method transfer
Perform method validation
Perform method verification
Perform method equivalency study
Perform analytical testing accurately
Perform analytical testing efficiently
Use Imex 'way of working'
Participate in 5S team initiatives
Practice good housekeeping
Follow safety procedures
Assess impact to products
Support regulatory submissions
Support regulatory queries
Write Standard Operating Procedures
Review Standard Operating Procedures
Write On the Job Training
Review On the Job Training
Conduct Laboratory investigations
Train colleagues on instruments
Train colleagues on methods
Perform review of test results
Write test procedures
Raise change controls
Complete change controls
Facilitate method transfer
Conduct training on new methods
Contribute to continuous improvement activities
Play active role in Tier processes
Update performance against metrics
Support solution development
Support solution implementation
Perform cleaning method development
Perform cleaning method validation
Follow site GDP practice
Prepare documentation
Perform method verification
Ensure training records updated
File training records
How You'll Work.
Team & Collaboration
5S team initiatives; Cross functional teams; Donating site meetings; Fellow QC colleagues
Communication Scope
Written communication; Verbal communication
Process & Methodology
Continuous improvement projects
Full Job Description
**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 is of the highest standard. **What You Will Achieve** In this role, you will: * Perform analytical method transfer, method validation, method verification and method equivalency study in accordance to Standard Operating Procedures (SOPs), adhering to ALCOA principles and Data Integrity requirements. * Perform analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements. * Use Imex "way of working" for day-to-day operations, problem solving, escalation and continuous improvements. * Participate in 5S team initiatives and practice good housekeeping, ensuring all safety procedures are followed. * Able to assess the impact to products based on compendial monograph changes/updates/introduction. * Able to support regulatory submissions and queries for post transfer activity. * Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory. * Conduct Laboratory investigations and propose CAPA for the identified root cause. * Train colleagues in hands on training of instruments and methods written * Perform review and approval of test results. * Able to write position paper, protocols, reports and test procedures. * Ability to handle QTS/eQMS actions and raise and complete change controls for changes with GMP impact. * Involve in regular meeting with donating site and facilitate the smooth transfer of the methods. * Con
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