Senior Associate Scientist, Investigations and Compliance Specialist

Pfizer•St. Louis, MO
•$68,600 - $114,300•Hybrid

About The Position

The Investigations and Compliance Specialist works within Pfizer’s Research & Development division to support the translation of science and technology into therapies and vaccines. The role focuses on quality-system investigations, compliance with quality and regulatory standards, audit and inspection support, and analysis of investigation and audit data to identify and implement improvements. The position is hybrid and may be eligible for relocation assistance based on business needs and eligibility.

Requirements

  • BA/BS in microbiology, molecular biology, biochemistry, or a related field and at least 3 years of experience in a GMP microbiology laboratory; or an MBA/MS and at least 1 year 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 in 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 tools such as ChatGPT or Microsoft Copilot, to support problem solving and productivity.
  • Curiosity about how AI tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
  • Must be authorized to work in the United States by any employer; U.S. work visa sponsorship is not available.
  • Requires permanent work authorization in the United States.

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 tools such as ChatGPT or Microsoft Copilot, to support problem solving and productivity; curiosity about improving outcomes and understanding 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 while following procedures and general instructions.
  • Contribute to immediate work-group goals and collaborate with team members.
  • Prioritize work to meet project deadlines and contribute as a team member.

Benefits

  • 401(k) plan with Pfizer matching contributions and an additional Pfizer Retirement Savings Contribution.
  • Paid vacation, holidays, 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 eligibility.
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