Senior Quality Assurance Specialist (United States - Michigan - Rochester)

This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

USE YOUR POWER FOR PURPOSE

Every day, Pfizer's 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. 

WHAT YOU WILL ACHIEVE

In this role, you will:

• Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.

• Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.

• Approve investigations and change control activities to maintain compliance with configuration management policies.

• Contribute to moderately complex projects, managing time effectively and developing short-term work plans.

• Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.

• Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.

• Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.

HERE IS WHAT YOU NEED (Minimum Requirements)

•   Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 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 in quality administered systems.

• Strong organizational skills and attention to detail.

• Experience with regulatory compliance and documentation.

• Ability to mentor and review the work of other colleagues.

• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to aseptically gown.

• This is a penicillin manufacturing facility. All candidates applying must NOT be allergic to penicillin.

• Able to lift 25-30 lbs.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Weeknight and weekend work may be required.

OTHER JOB DETAILS

Work Location Assignment: On Premise

Last Date to Apply for Job:  July 27, 2026

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 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.

Pfizer endeavors to make    accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email   View email address on apply.placed-app.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on  Pfizer Careers .

Quality Assurance and Control