QA Manager, Finishing and Logistics Focus Factory
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Job Location:
Rocky Mount, NC - USA
Monthly Salary:
$ 102900 - 171500
Posted on:
21 days ago
Vacancies:
1 Vacancy
Job Summary
Use Your Power for Purpose
Every day everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture which is both science and risk-based is designed to be flexible innovative and customer-oriented. Whether your role involves development maintenance compliance or analysis through research programs your contributions are crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards making a real difference in the lives of those who rely on our products.
What You Will Achieve
You will be a member of Pfizers dedicated and highly effective quality assurance team. The Quality Assurance (QA) Manager is responsible for providing quality oversight for activities conducted in the various manufacturing business units and the warehouse focus factory (FF). The manager must have fundamental knowledge of the principles and concepts of cGMPs of pharmaceutical manufacturing and the site production processes. The role ensures adherence to regulatory expectations and GxPs.
The QA Mgr must monitor process performance and Pfizer Quality Systems to ensure conformance with area procedures manufacturing parameters regulatory standards and specifications. Must be a critical thinker with the ability to effectively diagnose complex problems and identify sustainable solutions for technical challenges. The QA Mgr is responsible for colleague training and development and must motivate and inspire the team to ensure adherence to the Pfizer Core manager reports to the QA FF Sr Manager and manages the FF QA Specialist I (4-6).
How You Will Achieve It
Responsible for directing QA Specialists I workload and development.
Approve batch record changes process parameters and specifications.
Create and revise departmental Standard Operating Procedure (SOPs).
Review and approve site SOPs.
Perform review and approval of:
Impact assessments (for Change controls and deviations incidents)
Event reports (ERs)/Quality Assurance Reports (QARs) and associated CAPAs
Change control action items
Responsible for providing leadership strategic planning and oversight in the development and maintenance of the overall area processes.
Be able to perform all QA Specialist II tasks.
Serve as liaison for site internal/external audits (eg. Pfizer Centre One (PC1) and various Health Authorities).
Serve as a delegate to the QA Senior Manager (eg: meetings)
Review/Approve DI Equipment Audit Trail Reviews/Cal/PM reviews and routine validation activities as assigned
Lead/Support Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEx tools.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelors degree with at least 4 years of
experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR an associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experienceExperience in parenteral or related drug manufacturingin pharmaceutical industry with a good understanding of global regulatory requirements.
Direct experience with conducting and/or reviewing and approving quality investigations.
Strong interpersonal skills and proven track record of teamwork adaptability innovation and initiative required.
Strong oral/written communications skills and leadership skills required.
Sound knowledge of current Good Manufacturing Practices (cGMP).
Exceptional interpersonal skills; demonstrate the ability to collaborate and communicate with all colleagues within the organization.
Bonus Points If You Have(Preferred Requirements)
ASQ CQE certification
Experience with a clean room environment environmental monitoring and aseptic manufacturing requirements.
Experience with sterilization processes and validation requirements.
Experience in production batch record review investigation of nonconformance root cause analysis and change control management
Strong attention to detail excellent organizational interpersonal and communication skills (oral and written)
Good judgment and correct decision making based on company procedures/standards technical experience and industry guidance / regulatory requirements
Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment.
PHYSICAL/MENTAL REQUIREMENTS
Specific area/grade gowning required.
Capable of residing in a controlled environment for more than three (3) hours.
Capable of standing for periods of more than one (1) hour.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be able to support during production 24/7 or 24/5 as required
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.
Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Required Experience:
Manager
Key Skills
- Lean Manufacturing
- Kanban
- FileMaker
- Process Improvement
- Packaging
- Apache Pig
- Auto Painting
- Production Planning
- Quality Control
- Baking
- Supervising Experience
- Manufacturing
About Company
Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.
