Über diese Specialist QO Stelle bei Pfizer
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
- 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)
- 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
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
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 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. This position requires permanent work authorization in the United States.
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Quality Assurance and Control