Pfizer

Quality Compliance Engineer

Pfizer  •  Rochester, NY (Onsite)  •  1 day ago
Apply
AI can make mistakes so check important info. Chat history is never stored.
68
AI Success™

Job Description

USE YOUR POWER FOR PURPOSE

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.

The Quality Compliance Engineer supports the Quality Organization by ensuring compliance with applicable regulatory requirements, company quality systems, and current Good Manufacturing Practices (cGMP). This role plays a key part in driving continuous improvement initiatives, leading quality‑related projects, and partnering cross‑functionally to strengthen compliance, efficiency, and inspection readiness across the site.

WHAT YOU WILL ACHIEVE

In this role, you will:

  • Lead and support continuous improvement initiatives focused on strengthening quality systems, reducing repeat deviations, and improving right‑first‑time execution.

  • Apply root cause analysis tools (e.g., 5 Whys, Fishbone, data trending) to identify systemic issues and drive sustainable solutions.

  • Partner with cross‑functional teams to simplify processes, improve documentation quality, and enhance compliance efficiency.

  • Support development and monitoring of quality metrics to identify trends, risks, and opportunities for improvement.

  • Provide quality oversight and guidance for engineering activities such as equipment qualification, process validation, and facility or utility changes.

  • Participate in risk management activities (e.g., FMEA, hazard analysis) to support robust design and compliant execution.

  • Support development and monitoring of quality metrics to identify trends, risks, and opportunities for improvement.

  • Partner with Manufacturing, Engineering, Validation, Supply Chain, and Quality teams to ensure compliant execution of site activities.

HERE IS WHAT YOU NEED (Minimum Requirements)

  • Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevantexperience.

  • Experience in Quality Assurance, Quality Compliance, or Engineering support roles.

  • Experience leading continuous improvement or remediation initiatives.

  • Familiarity with root cause analysis, risk management, and quality metrics.

  • Experience supporting regulatory inspections and audits.

  • Knowledge of electronic quality management systems (eQMS).

BONUS POINTS IF YOU HAVE (Preferred Requirements)

  • Continuous improvement mindset.

  • Project planning and execution.

  • Regulatory and compliance expertise.

  • Problem solving and data‑driven decision making.

  • Cross‑functional collaboration and influence.

  • Attention to detail with a focus on sustainability and effectiveness.

PHYSICAL/MENTAL REQUIREMENTS

Ability to work in manufacturing and controlled environments, including gowning requirements.

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

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This is a 1st shift position that may require Occasional offshift or weekend support may be required to support operations, projects, or inspections.


Relocation support available

OTHER JOB DETAILS

Work Location Assignment: On Premise

Last Date to Apply for Job: April 8, 2026


The annual base salary for this position ranges from $99 200,00 to $165 400,00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12,5% of the base salary and eligibility to participate in our share based long term incentive program. 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 makewww.pfizer.com/careersaccessible 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 emaildisabilityrecruitment@pfizer.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.


Quality Assurance and Control

Pfizer

About Pfizer

We’re celebrating over 175 years of daring scientific innovation—and we’re not done yet. Let’s outdo yesterday. Protect your health at PfizerForAll.com

For additional information on our guidelines, please visit http://www.pfizer.com/community-guidelines

Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
New York, New York
Year Founded
Unknown
Social Media