As a member of Pfizer’s dedicated and highly effective quality assurance and control team, your knowledge of quality control will support our quality programs. Your ability to analyze chemical, biological, or microbiological products will help us manage our quality. Your contribution to analytical testing will help Pfizer provide safe drugs to its patients.
Your expertise with unique Quality Control instruments will help us meet accuracy specifications for sample management, retains management, interpretation, and evaluation. You will also establish requirements for the transfer of methodology from R&D. As an associate, your focus will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will foster a collaborative teaming environment for your colleagues.
Your hard work and dedication will help Pfizer achieve new milestones and assist patients across the globe.
How You Will Achieve It
- Manage receipt, storage, and handling of Stability Samples.
- Ensure training records are updated and correctly filed to reflect current testing capabilities.
- Perform sampling and labeling of materials as per defined procedures and verification of all equipment/instruments.
- Interpret and evaluate data in terms of accuracy, precision, trends, and potential Good Manufacturing Practices (cGMP) impact, and recommend appropriate corrective actions.
- Ensure all documentation and quality records are maintained in accordance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements and filed according to existing policies.
- Review and revise Standard Operating Procedures (SOPs), analytical methods, and related procedures/documents to keep them current.
- Perform analyses on finished products, raw materials, and components, including entry, review, and/or approval of data in a computerized database, and generate EMS reports.
- Conduct microbiological protocols as needed.
Qualifications
Must-Have:
- Bachelor’s degree in Pharmacy or Master’s in Chemistry/Pharmacy
- 1-5 years of experience
- Demonstrated technical skills in method validation/method transfer and testing
- Ability to read and understand applicable compendial methods, SOPs, technical procedures, and governmental regulations
- Knowledge of GMP and its application standards, processes, and policies
- Excellent organizational skills and strong ability to multi-task
- Strong written and verbal communication skills
Nice-to-Have:
- Laboratory work experience with analytical HPLC (High Pressure Liquid Chromatography) technique
- Experience leading continuous improvement projects
- Knowledge of lean manufacturing, Six Sigma methodologies, and statistics
- Ability to contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
Work Location Assignment: On Premise