Pfizer Specialist Quality Operations in Kalamazoo, Michigan
Candidate will be responsible for lot release, change control review and approval, manufacturing support, record approvals, COA generation/review, and test plan changes. The API QA team is a focused team whose responsibility is to ensure timely release of conforming API.
Independently, with minimal guidance, consistently produces quality work and may mentor others in one or more of the following:
Lot Release: Evaluates data and releases Pfizer produced products that conform to corporate, customer, and regulatory standards. Maintains associated test plans. Completes compendial reviews and corresponding test plan updates by assigned deadlines.
Deviation Support: Reviews Laboratory Investigation Reports as part of lot release decisions. Reviews and approves Readily Apparent and Assignable Cause LIRs. Implements corrective and preventative actions as assigned.
Change Control: Evaluates and approves changes to manufacturing and packaging equipment and processes, testing, IT systems and other GMP documents and programs. This includes change control that is internal to Kalamazoo, documented through the Quality Tracking System (QTS) and also changes that are controlled externally through the Product Change Report (PCP/PCR) system in collaboration with CMC. Reviews and may help develop product and process validation strategies.
Maintains Quality Systems and ensures that products conform to regulatory, compendial and Pfizer Quality Standards. This includes review of compendial updates and implementation of associated changes.
Participates in internal GMP audits and supports customer and regulatory audits.
Proven written and oral communication skills based on good Pfizer leader behaviors.
Education and Experience:
Education: BS in Chemistry, Microbiology, Engineering, or other science related discipline.
Experience: Prefer at least 2 - 4 years of pharmaceutical experience, active pharmaceutical ingredient manufacturing, or quality operations. Experience at a manufacturing site preferred.
Independently, with minimal guidance, consistently produces quality work. Must be able to work in a team environment within own team and interdepartmental teams. Must work under short timelines while maintaining quality work. The successful candidate must 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 are critical characteristics of this position. Must demonstrate flexibility/agility and engagement in a changing environment
Office position with some time spent in the production environment. For internal audits, must be able to traverse stairs in a production environment while wearing appropriate personal protective equipment (PPE), including safety shoes, hard hat and safety glasses. Occassional weekend or evening work may be necessary.
Must be able to perform complex data analysis, critical thinking, and manage conflicting and shifting priorities.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Weekends, holidays, or offshift may be required at times to meet critical business needs. Minimal travel.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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Last Date to Apply for Job: 5/9 /18
Eligible for Relocation Package
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.