Manufacturing Quality Support Senior Associate
Manufacturing Quality Support Senior Associate
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Job Description
Use Your Power for Purpose
Every day Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative always putting the patient first. Whether you are involved in development maintenance compliance or research analysis your contribution directly impacts patients.
What You Will Achieve
In this role you will:
Participate/lead manufacturing area(s) shutdown activities.
Approve planned alarms and work orders (WO)
Board of Health (BOH) sample management
IMEX Element Owner
Compliance Walkthroughs
Aseptic gowning occasionally
Support site regulatory inspections
Facilitate internal & external meetings and provide training/presentations/updates/report-out to QA and Manufacturing colleagues on a regular basis.
Lead & suggest Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEX tools and the one best way philosophy.
Review/approve new/existing procedures (SOPs MBRs Job Aids etc.) in Documentum to ensure proposed critical changes to procedures and/or processes are completed/documented appropriately.
Perform Annual Product Records Review (APRR)
Assist with other tasks as needed such as: Complaint Investigation Review/Approval Internal Audits/Assessments FDA response coordination Gap Analysis Regulatory Inspection Readiness.
Provide guidance/coaching to less experienced QA and Manufacturing colleagues.
Work cross-functionally with various business groups (i.e. Operations Tech Ops Automation Compliance Process Engineering Investigators etc.)
Represent QA in cross-departmental/cross-site meetings. Independently makes decisions with minimal assistance from QA management
Here Is What You Need (Minimum Requirements)
High school diploma (or equivalent) with 8 years of experience or associates degree with 6 years of experience or BA/BS with 2 years of experience or MBA/MS with any years of relevant experience
Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
Strong critical thinking skills
Ability to work effectively within own team and interdepartmental teams
Good working knowledge of Microsoft Excel and Word
Proactive approach to problem-solving
Bonus Points If You Have (Preferred Requirements)
Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) used in the Pharmaceutical Industry.
Knowledge of and experience in a biopharmaceutical/pharmaceutical cGMP environment.
Knowledge of electronic systems including Trackwise Documentum/PDOCs SAP gLIMS Microsoft Office.
Good judgment and correct decision making based on company procedures/standards technical experience and industry guidance / regulatory requirements.
Collaboration skills and the ability to independently engage with a wide range of co-workers customers and management to gather the input and background knowledge needed to complete assignments.
Physical / Mental requirements
Standing/sitting for periods of more than one (1) hour.
Non-Standard work schedule travel or environment requirements
This role may occasionally require on-call after hours and weekend support.
Other details
Last Day to apply: May 28th 2025
Relocation support available
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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 providers 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. This position requires permanent work authorization in the United States.
Required Experience:
Senior IC
Employment Type
Full-Time
