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Manufacturing Quality Engineer (Finishing)

Company

Pfizer

Address , Rocky Mount, Nc
Employment type FULL_TIME
Salary
Expires 2023-06-23
Posted at 1 year ago
Job Description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
  • Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
  • Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
  • Create, review and approve deviations and consistently produce quality work.
  • Help to define appropriate action plans for improvement and follow-up and communicate action closures.
  • Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
  • Create, review and approve Good Manufacturing Practices {also cGMP} audit reports.
  • Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
  • Lead/Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.
  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
  • Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact.
  • Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
Qualifications
Must-Have
  • Experience in Quality administered systems
  • OR an Associate's degree with four years of experience;
  • Effective written and oral communication skills
  • OR a Bachelor's degree with 0+ years of experience.
  • Applicant must have High School Diploma (or Equivalent) with six years of relevant experience;
  • Ability to work in a team environment within own team and interdepartmental teams
Nice-to-Have
  • Experience of writing and managing deviations
  • Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
  • Experience at a manufacturing site
  • Experience in pharmaceutical industry
  • Sound knowledge of current Good Manufacturing Practices {part of GxP}

PHYSICAL/MENTAL REQUIREMENTS
  • Sit up to 2 to 4 hours
  • Stand up to 8 to 10 hours
  • Occasionally lift a maximum of 20 pounds 3 times per shift
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Day shift 12 hour 2,2,3 rotating schedule. Every other weekend will be a working weekend.

Work Location Assignment: On Premise
Relocation Assistance available: NO
Last date to apply: 5/4/2023
Relocation assistance may be available based on business needs and/or eligibility.
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
#LI-PFE