Manufacturing Quality Engineer- Quality Distribution

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.

The Distribution Manufacturing Quality Engineer provides oversight and guidance in warehouse operations, ensuring continuous facility and GMP compliance in the R1 warehouse and off-site warehouse facilities. The Manufacturing Quality Engineer will coach manufacturing and distribution warehouse personnel on proper GMP and SOP compliance and empower them to identify and escalate quality issues, to ensure quality product.

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.

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.

• Conduct evaluations and oversight of production personnel and processes to ensure procedures are being followed in accordance with GMP compliance and regulatory guidelines.
• Implement process improvements with a focus on quality processes.
• Provide input and decision making for quality on the shop floor regarding manufacturing and deviations. Provide corrective action as necessary.
• Work closely with Manufacturing and other support functions to troubleshoot during unexpected events.
• Complete projects as identified by management.
• Create, review and approve Good Manufacturing Practices {also cGMP} audit reports.
• 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 deviations and consistently produce quality work.
• 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. Escalate as necessary.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
• Participate in Yellow/Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
• Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.
• May participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.

• Bachelor's Degree (Science degree preferred).
• 0-2 years previous pharma experience preferred.
• Experience in Quality administered systems
• Sound knowledge of current Good Manufacturing Practices {part of GxP}
• Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative required.
• Strong oral/written communications skills and leadership skills required.
• Ability to work well with all levels of personnel throughout the facility.
• Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment.
• Available to work off-shifts and/or weekends.

• Experience at a manufacturing site
• 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
  

PHYSICAL/MENTAL REQUIREMENTS

• Stand up to 8 to 10 hours
• Sit up to 2 to 4 hours
• Occasionally lift a maximum of 20 pounds 3 times per shift
• Walking and climbing stairs
• Work around and close to moving equipment
  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to work overtime as required supporting business needs.

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.