Environmental Monitoring Process Specialist

Pfizer • Rochester, MI

7d • Onsite

About The Position

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. What Will You Achieve You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight.

Requirements

• Bachelor’s degree with 0+ years of experience, OR an Associate's degree with 4 or more years of experience, or a high school diploma (or equivalent) with 6 or more years of relevant experience.
• Strong understanding of regulatory requirements and compliance standards.
• Excellent attention to detail and organizational skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Effective written and verbal communication skills.
• Must not be allergic to Penicillin
• Candidate must be able to complete aseptic gowning training and be able to work gowned.
• Candidate will need to understand principles of scientific writing and design of experiments.
• Permanent work authorization in the United States.

Nice To Haves

• Demonstrated working knowledge and understanding of EM procedures, sample processing / analysis, and lab calculations
• Working knowledge of contemporary analytical techniques
• Knowledge of Good Manufacturing Practices also cGMP, validation principles, audit techniques, and working knowledge of statistics
• Experience with audit processes and corrective action plans.
• Strong problem-solving skills.
• Knowledge of drug/device product requirements
• 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

Responsibilities

• Recognize and anticipate the Environmental Monitoring's (EM) needs, and coordinate activities required from Quality Control (QC) in the transfer of products and perform product quality review.
• Ensure compliance with regulatory requirements and internal policies.
• Conduct testing, audits and inspections to identify areas of non-compliance.
• Develop and implement corrective action plans to address compliance issues.
• Maintain accurate records of compliance activities and findings.
• Provide training and support to on testing, systems and techniques.
• Collaborate with cross-functional teams to ensure compliance across all operations.
• Monitor changes in regulations and update compliance programs accordingly.
• Prepare, review and submit deviation and compliance reports to management and regulatory bodies.
• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

Benefits

• 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
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree