Senior Specialist QO

About this role

Use Your Power for Purpose 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.  

What You Will Achieve In this role, you will: • 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 • Review your own work and potentially mentor others, exercising judgment and becoming a resource for colleagues • 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

Here Is What You Need (Minimum Requirements) • High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience • Strong understanding of validation principles and practices • Experience with regulatory requirements and guidelines for validation • Ability to work independently and make decisions in ambiguous situations • Excellent communication and interpersonal skills • Proficiency in computerized systems and software applications

Bonus Points If You Have (Preferred Requirements) • 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

Physical / Mental requirements • Working in a production environment which may include proper gowning for the area • Lifting items (typically less than 25 lbs) • Working with or around chemicals • Position also requires office work, which includes working at a computer workstation

Non-Standard work schedule, travel or environment requirements • Position may require off-hours, weekends and/or holidays to meet business or customer needs • Proper gowning for production areas, including aseptic gowning, may be required

Other job details • Last day to apply: September 8th, 2026. • Work Location Assignment: On Premise

   Work Location Assignment: On Premise 
The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.



 Relocation assistance may be available based on business needs and/or eligibility. 
 Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. 
 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 hesita

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