Specialist QO

Pfizer • Kalamazoo, MI

6d • Onsite

About The Position

At Pfizer, everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will be instrumental in ensuring that our products meet the highest standards of quality and safety. The successful candidate will provide quality oversight for cleaning validation program requirements at the Kalamazoo site. This role ensures that cleaning processes, related change controls, and validation documentation align with global Revolution processes and procedures. The ideal candidate will bring relevant skills and experience in cleaning validation.

Requirements

• Applicant must have a bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
• Strong organizational skills and the ability to manage changing deadlines
• Basic understanding of validation principles and practices
• Ability to work in a team environment and collaborate effectively with colleagues
• Excellent communication and interpersonal skills
• Proficiency in computerized systems and software applications
• Permanent work authorization in the United States.

Nice To Haves

• Current or previous experience in role related to cleaning validation
• Strong understanding of global Revolution cleaning validation process and procedures
• Comprehensive knowledge of GMP regulations and guidance, including 21 CFR Parts 11, 210 & 211, EC Annex 15, and ICH 7
• Strong background in problem-solving, negotiations, and data integrity principles
• Good understanding of risk management methodologies and their application to pharmaceutical operations
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance processes

Responsibilities

• Apply skills and discipline knowledge to contribute to departmental work and make decisions to resolve moderately complex problems
• Operate in ambiguous situations, determining objectives of assignments and seeking directional review when necessary
• Establish and implement cleaning validation strategies, ensuring compliance with corporate policies
• Review and approve change controls, ensuring validation impact assessments and appropriate testing including generation and/or review/approval of cleaning validation documentation to maintain validated states
• Collaborate with Operations, Quality, Technical groups, and other site/network groups to meet business and compliance requirements
• Deliver visual inspection training and provide input to equipment modifications or replacements

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level