Senior Associate Scientist, Investigations and Compliance Specialist
Pfizer
Summary
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered in New York City, founded in 1849 by German entrepreneurs Charles Pfizer and Charles F. Erhart. As one of the world's largest pharmaceutical companies, Pfizer develops and produces medications and vaccines across multiple therapeutic areas including immunology, oncology, cardiology, endocrinology, and neurology. The company is renowned for breakthrough drugs such as Lipitor, Viagra, and more recently, the Pfizer-BioNTech COVID-19 vaccine. With approximately 81,000 employees globally and operations in about 200 countries, Pfizer maintains 37 manufacturing sites worldwide. The company's current strategic focus includes oncology, rare diseases, and innovative vaccine development, while implementing significant cost-saving initiatives. Pfizer continues to advance its research pipeline with over 100 projects and maintains a strong commitment to scientific innovation and global healthcare access.
Job description
What You Will Achieve
- 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
Here Is What You Need (Minimum Requirements)
- 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
Bonus Points If You Have (Preferred Requirements)
- Investigation writing experience
- Problem-solving skills and the ability to make decisions based on limited options
- Initiative and proactive approach to tasks and projects
- Ability to thrive in a dynamic environment
Requirements
- 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
Benefits
- 401(k) Matching
- Retirement Savings Contribution
- Paid Vacation
- Paid Holidays
- Paid Personal Days
- Paid Caregiver Leave
- Paid Parental Leave
- Paid Medical Leave
- Medical Insurance
- Prescription Drug Coverage
- Dental Insurance
- Vision Coverage
Company overview
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered in New York City, founded in 1849 by German entrepreneurs Charles Pfizer and Charles F. Erhart. As one of the world's largest pharmaceutical companies, Pfizer develops and produces medications and vaccines across multiple therapeutic areas including immunology, oncology, cardiology, endocrinology, and neurology. The company is renowned for breakthrough drugs such as Lipitor, Viagra, and more recently, the Pfizer-BioNTech COVID-19 vaccine. With approximately 81,000 employees globally and operations in about 200 countries, Pfizer maintains 37 manufacturing sites worldwide. The company's current strategic focus includes oncology, rare diseases, and innovative vaccine development, while implementing significant cost-saving initiatives. Pfizer continues to advance its research pipeline with over 100 projects and maintains a strong commitment to scientific innovation and global healthcare access.