Sr. Specialist QO

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.

ROLE SUMMARY

This posting is for a position on the Supplier Quality (SQ) QA team providing real time quality impact support (including off shift and weekends) for the incoming packaging and raw materials team at the Kalamazoo site. The primary responsibility of this role is to lead and ensure the successful execution of the Reduced Testing Program including coordination across cross-functional teams data analysis documentation and continuous improvement initiatives. The candidate will serve as the subject matter expert for reduced testing driving compliance efficiency and alignment with regulatory and internal quality standards.
As a secondary responsibility the role supports the incoming packaging team. This includes inspection readiness deviation investigations supplier quality interactions general warehouse support and ensuring packaging components meet specifications and quality requirements.
This dual-focus position requires strong analytical skills attention to detail and the ability to manage multiple priorities.

What You Will Achieve

In this role you will:

• Lead the implementation maintenance and continuous improvement of the Reduced Testing Program.
• Collaborate with Quality Operations Regulatory and Supply Chain teams to ensure alignment and compliance.
• Analyze historical data and trends to support justification for reduced testing strategies.
• Maintain and update program documentation protocols and risk assessments. Facilitate approval process for the reports.
• Ensure adherence to cGMP regulatory requirements and internal quality standards.
• Independently provide Real Time Quality impact assessments and decisions on packaging material 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.
• Evaluates data and releases incoming packaging and raw materials that conform to corporate and regulatory standards. Maintains associated test plans.
• Qualifies new vendors and materials via the material evaluation (ME) process.
• Effectively leads/facilitates/participates/completes cross-functional team investigations for vendor complaints and significant deviations.
• Utilize tools such as Method 1 and Pfizer Human Performance (PHP) tools in the course of the investigations
• Lead/Participate in QRM assessments that gain approval through Site and Area QO Management
• Participate in Green/Black belt projects RFT% Improvement projects CAPA Effectiveness etc as appropriate
• Independently assess a wide range of Change Control activities (MEs Protocol development SOP and batch record changes) to determine potential Quality and Operational GMP impacts
• SME support during Regulatory/Customer audits including contributions to strategies to successfully respond to auditor concerns
• Support regulatory in the development of regulatory submission packages.
• Effectively communicate complex technical issues to all levels of Management (including outside of Quality)

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)

• Experience: Quality Assurance/Control in lot release deviations and floor/product support preferred along with advanced experience with SAP gLIMS QTS SMS and Batch Tracker.
• Sr. Specialist QO must have the ability to effectively communicate through written and oral means. Understand the quality systems and be able to drive consistency between the customers and Pfizer. This person needs to understand the concepts incorporated in Quality Assurance in a GMP environment along with negotiation and problem-solving skills. Must be capable of multi-tasking job tasks through multiple customer and plant processes. Experience with working in a cross-functional team environment preferred.

PHYSICAL/MENTAL REQUIREMENTS

N/A

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

This is a 1st shift position that may require occasional weekend/evening work supporting external and internal customers.

Relocation assistance may be available based on business needs and/or eligibility.