Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our flexible, innovative, and customer-oriented quality culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.
Role Summary
This position is for a Quality Control Laboratory Analyst in the Kalamazoo Quality Laboratories working on first shift. Responsibilities will be focused within the drug product chemistry labs and incoming inspection. Technologies employed in the Drug Products Laboratory include but are not limited to HPLC, GC, titrations, Karl Fisher, UV, IR, pH, Microscopy, and general analytical procedures. Incoming inspection performs visual and instrumental inspections of packaging materials, evaluates data for accuracy and completeness, and supports investigations related to material quality concerns.
What You Will Achieve
Work effectively in a fast-paced, customer-oriented, team laboratory environment
Independently perform testing and documents results for qualitative or quantitative assays on samples using techniques that vary from use of standard laboratory equipment to highly modern and automated instrumentation.
Troubleshoots test methods and analytical equipment.
Write equipment qualification protocols and reports as needed.
Proactively identify and resolve basic complexity problems, considering wider implications.
Complete assignments independently, selecting appropriate methods, and ensuring team assignments are completed.
Conduct peer review (record checking) of laboratory data packets.
Adhere to Pfizer standards, guidelines, and values, influencing teams, and contributing to the development of departmental standards and guidelines.
Execute method validation activities as needed.
Update SOPs, update test methods and write reports as needed.
Assist in Laboratory Investigation Reports by leading or providing expertise as SME.
Coordinate and lead projects with impact to unit.
Maintain high standards of safety and housekeeping, participate in Continuous Improvement projects, and ensure adherence to all policies and procedures, while providing training and conducting peer reviews.
Here Is What You Need (Minimum Requirements)
High School Diploma or GED with 6+ years of experience
Or an associate's degree in chemistry or a related science with 4+ years of experience
Or a bachelor's degree in chemistry or a related science with 2+ years of experience
Demonstrated proficiency in at least one high complexity technology (HPLC, UHPLC, GC, etc.) or 2+ medium complexity technologies (TLC, Titrations, Water Testing, etc.)
The successful candidate must also have demonstrated the ability to quickly learn new skills/techniques.
High productivity and the ability to multi-task coupled with a low error rate and attention to detail.
Ability to write clear technical documents
Good organizational and time management skills
Experience troubleshooting test methods and analytical instrumentation.
Experience performing peer review of laboratory data
Knowledge of Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)
Candidate must have in-depth technical knowledge in one or more analytical techniques, such that they would be considered a subject matter expert in the given technology.
Bonus Points If You Have (Preferred Requirements)
Subject matter expertise in HPLC
Experience performing quality inspection testing
Experience with SAP, gLIMS, and Batch Tracker
Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to…