Investigations & Compliance Scientist — Hybrid

Pfizer

Andover (MA)

Hybrid

USD 69,000 - 114,000

Full time

48 hours ago
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Job summary

Pfizer is seeking an Investigations and Compliance Specialist within the Research & Development division. The role focuses on authoring investigations, ensuring strict GMP adherence, and supporting audits and regulatory reviews, with emphasis on data-driven improvements.

Hybrid work location in the United States; base salary ranges and bonuses are detailed in the job posting. Strong technical writing, documentation, and AI tool experience are valued for effective problem solving and risk

Qualifications

  • BA/BS in microbiology, molecular biology, biochemistry, or related field with at least 3 years of experience in a GMP microbiology laboratory, or MBA/MS with 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 as part of cross-site, multi-disciplinary teams
  • Ability to extract relevant information from scientific literature
  • Ability to self-manage timelines and deliverables
  • Strong organizational skills with demonstrated attention to detail
  • 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

  • Author high quality and timely investigations within the Pfizer quality systems
  • Ensure investigations are conducted in strict adherence to appropriate quality and compliance standards
  • Promote adherence to root cause analysis and human error reduction tools
  • Support internal and external audits and inspections, including coordination of audit requests and responses
  • Perform global procedure compliance assessments
  • Regularly and proactively review compendia and regulatory requirements
  • Be a proactive member of internal quality forums
  • Analyze data from investigations, audits, and inspections to identify, recommend, and implement improvements
  • Choose between alternatives to solve moderately complex problems and follow procedures with general instructions
  • Contribute to the achievement of immediate work group goals and collaborate with other team members
  • Prioritize work to meet project deadlines and ensure participation and contribution as a team member

Job description

Pfizer is seeking an Investigations and Compliance Specialist within the Research & Development division. The role focuses on authoring investigations, ensuring strict GMP adherence, and supporting audits and regulatory reviews, with emphasis on data-driven improvements.

Hybrid work location in the United States; base salary ranges and bonuses are detailed in the job posting. Strong technical writing, documentation, and AI tool experience are valued for effective problem solving and risk

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