Pfizer Specialist Quality Operations in Kalamazoo, Michigan

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

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.

QUALIFICATIONS

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.

Technical Skills:

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

PHYSICAL/MENTAL REQUIREMENTS

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.