QC Chemist – Raw Material Laboratory
Associate, 1+ Years
Pharmaceutical and biotechnology
ROLE SUMMARYThe Raw Material (RM) Chemist is responsible for scheduling prioritization, workload distribution, and laboratory process improvement for Raw Material testing at the Kalamazoo site. This includes communicating priorities to the lab and following up with customers on testing status. The Chemist performs LIR supervisor duties for atypical, OOS, questionable, and invalidated data occurrences and will cover data integrity responsibilities. The Chemist represents and/or leads the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of Quality Operations. This role provides leadership and technical expertise to assist the laboratory with troubleshooting, investigations, computer validation and instrument qualifications. The chemist may be involved in second checking of data and will perform assays as needed. This role has the responsibility of serving as Management Designee and will have limited input into the OTE colleague performance assessment process. The chemist may defend QO Laboratory Quality Systems during audits and inspections.
ROLE RESPONSIBILITIES • Leads and documents laboratory investigations for procedural deviations, atypical, OOS, questionable, and invalidated data occurrences. • Assures adherence to data integrity initiatives.• As a Subject Matter Expert (SME), represents the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of QO. Leads medium or high complexity project teams within QO tasked with improving laboratory or other quality systems. • Assists QO Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met. • Performs data quality inspection through Quality audits and 2nd check of laboratory data packets• Performs analytical assays during times of need. • Demonstrates a technical mastery of one or more techniques in fields such as: wet chemistry, chromatography, physical chemistry, or spectroscopy as well as a complete knowledge of laboratory operations including both technical and compliance aspects. • Applies knowledge of advanced techniques and procedures with recommendations and implementation of new or modified procedures or instrumentation for improved lab efficiency. • Trains others in the theory and practice of both laboratory techniques and quality systems including investigations, instrument qualifications, etc. • Independently writes SOPs, technical reports, project plans, instrument qualifications, etc. • Supports and may lead implementation of various elements of IMEx.• Performs analytical assays during times of need• Serves as management designee and will have limited input into the OTE colleague performance assessment process.
BASIC QUALIFICATIONS BA/BS, or MS in Chemistry, Biochemistry, or related science preferred with a minimum of 2 years related experience in Quality Operations.
PREFERRED QUALIFICATIONS• LIR / RAAC Author• Trained to execute and record check multiple Chemistry laboratory technologies
Job requires sitting, standing, walking, ability to type, and dexterity for handling glassware/laboratory equipment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Overtime may be necessary depending on business needs.
Relocation support available
Last Date to Apply for Job: November 30thEligible for Relocation Package: YESEligible for Employee Referral Bonus: YES#LI-PFE
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
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Quality Assurance and Control