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Posted 24 days ago
Quality Compliance Engineer
PfizerQuality Compliance Engineer
Perks & benefits
Health InsurancePaid LeaveRelocation Allowance
Requirements
Bachelor's degree with 4+ years experience, Master's degree with 2+ years experience, PhD with 0+ years experience, Associate's degree with 8+ years experience, High school diploma with 10+ years experience, Quality Assurance or Engineering experience, Continuous improvement leadership, Root cause analysis knowledge, Risk management expertise, eQMS knowledge, Non-allergic to penicillin
Skills
Quality AssuranceGMPRoot Cause Analysis
About the role
Responsibilities
- Lead and support continuous improvement initiatives to strengthen quality systems and reduce repeat deviations
- Apply root cause analysis tools such as 5 Whys and Fishbone to identify systemic issues and drive sustainable solutions
- Partner with cross-functional teams to simplify processes, improve documentation quality, and enhance compliance efficiency
- Support the development and monitoring of quality metrics to identify trends, risks, and opportunities for improvement
- Provide quality oversight for engineering activities including equipment qualification, process validation, and facility changes
- Participate in risk management activities such as FMEA and hazard analysis to support robust design and compliant execution
- Partner with Manufacturing, Engineering, Validation, and Supply Chain teams to ensure compliant execution of site activities
Requirements
- Bachelor's degree with 4+ years of experience, OR Master's degree with 2+ years, OR PhD with 0+ years, OR Associate's degree with 8 years, OR High school diploma with 10 years of relevant experience
- 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)
- Must not be allergic to penicillin (this is a penicillin manufacturing facility)
Preferred Qualifications
- Continuous improvement mindset and project planning expertise
- Strong regulatory and compliance expertise
- Proven problem-solving and data-driven decision-making skills
- Ability to collaborate and influence across cross-functional teams
- High attention to detail with a focus on sustainability and effectiveness
Benefits
- Competitive annual base salary and eligibility for Pfizer’s Global Performance Plan bonus
- 401(k) plan with Pfizer Matching Contributions and additional retirement savings contributions
- Comprehensive health benefits including medical, prescription drug, dental, and vision coverage
- Paid vacation, holidays, personal days, and paid caregiver/parental and medical leave
- Relocation assistance may be available based on business needs
About the Company
Pfizer is a global leader in the pharmaceutical industry, dedicated to delivering safe and effective products to patients through a culture rooted in science and risk-based compliance. We believe in our ability to improve future healthcare and transform millions of lives through innovation and individual ownership.
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Pfizer · Rochester
