Senior Associate Scientist, Investigations and Compliance Specialist

Pfizer • Saint Louis, MA

5d • Hybrid

About The Position

Within Pfizer’s Research & Development division, the Investigations and Compliance Specialist supports the development of medicines and vaccines by conducting quality investigations and advancing compliance. The role authors timely investigations within Pfizer quality systems, helps ensure adherence to quality and regulatory standards, supports audits and inspections, and uses data to identify and implement improvements. The specialist works with peers and leaders across sites and disciplines, manages competing priorities, and contributes to work-group goals and project deadlines.

Requirements

• BA/BS in microbiology, molecular biology, biochemistry, or a related field, plus at least 3 years of experience in a GMP microbiology laboratory; or an MBA/MS and one or more years of experience.
• Advanced technical writing skills.
• Strong documentation skills and attention to detail.
• Experience in Good Manufacturing Practices (cGMP) environments.
• Experience with GMP microbiology investigation processes.
• Experience with laboratory data systems such as LIMS, eQMS, and GDMS.
• Ability to interact effectively with peers and leaders on cross-site, multidisciplinary teams.
• Ability to extract relevant information from scientific literature.
• Ability to self-manage timelines and deliverables.
• Strong organizational skills and demonstrated attention to detail.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and productivity; curiosity about how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
• Candidates must be authorized to work in the United States by any employer; U.S. work visa sponsorship is not available.
• Permanent work authorization in the United States is required.

Nice To Haves

• Investigation writing experience.
• Problem-solving skills and ability to make decisions based on limited options.
• Initiative and a proactive approach to tasks and projects.
• Ability to thrive in a dynamic environment.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and productivity; curiosity about how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

• Author high-quality, timely investigations within Pfizer quality systems.
• Ensure investigations follow applicable quality and compliance standards.
• Promote the use of root cause analysis and human error reduction tools.
• Support internal and external audits and inspections, including coordinating requests and responses.
• Perform global procedure compliance assessments.
• Review compendia and regulatory requirements proactively and regularly.
• Participate proactively in internal quality forums.
• Analyze investigation, audit, and inspection data to identify, recommend, and implement improvements.
• Choose among alternatives to solve moderately complex problems and follow procedures with general instructions.
• Contribute to immediate work-group goals and collaborate with team members.
• Prioritize work to meet project deadlines and participate as a contributing team member.

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.
• Medical, prescription drug, dental, and vision coverage.
• Eligible to participate in Pfizer’s Global Performance Plan, with a bonus target of 7.5% of base salary.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior