Manager Quality Operations

WHY PATIENTS NEED YOU

This posting is for a position in the QA API team as the Subject Matter Expert for Stability and Annual Product Reviews (APRR). This colleagues responsibilities will include being responsible for Stability and APRR’s of API’s manufactured in Kalamazoo.  They will also be responsible for floor support including lot release.

HOW YOU WILL ACHIEVE IT

• Independently provide Real Time Quality impact assessments and decisions on API product issues
• Ability to handle complex and detailed situations
• Accurately assess consequences of decisions
• Accurately assess potential Regulatory impacts on a Global basis
• Immediately escalate issues with potential market or stability impact
• Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives.
• Review and approve stability reports and protocols
• Review and approve stability study status changes
• Investigation of stability incidents
• Review APRR’s for accuracy against the raw data and for trends
• Floor support including lot release

BASIC QUALIFICATIONS

Education: BS/BA in Chemistry, Microbiology, Biochemistry, Biology, Chemical Engineering or other science related discipline

Experience: 5-8 years pharmaceutical experience with a bachelors or 3-6 years with a masters. Quality Assurance/Control experience required along with advanced experience with SAP, LIMS, QTS, and PFO/Batch Tracker.  Lot release and deviation experience also required.

PREFERRED QUALIFICATIONS

Education: BS/BA/MS in Chemistry and Biochemistry preferred

Experience: Quality Assurance/Control experience in lot release, deviations, Annual Product Reviews, and Stability preferred along with advanced experience with SAP, LIMS, QTS, PFO/Batch Tracker, and gLIMS.

ORGANIZATIONAL RELATIONSHIPS

Works closely with API operations, supply, laboratory, SLS, Stability Administration, and quality operation peers and all levels of leadership. 
 

PHYSICAL/MENTAL REQUIREMENTS

Office position with time in the production environment.

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.  Must have effective written and oral communication skills.

Other Job Details:

• Last Date to Apply for Job: December 21st, 2021

• Eligible for Relocation Package

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.

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.

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.

Quality Assurance and Control

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