QC Scientist II

Pfizer • Andover, MA

4d • Onsite

About The Position

The qualified candidate must have the experience and ability to perform microbiological assays within the Quality Science and Technology group. Demonstrate the ability to interpret results and design/perform microbiological validation assays involving commercial in-process cell culture, purification and bulk drug substance samples, raw materials, and process & cleaning validation samples. Experience with molecular based techniques, including PCR-based assays is a plus. Assays are qualitative, quantitative, and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements and per standard operating procedures. What You Will Achieve In this role, you will: Perform all work in compliance with cGMPs and site requirements. Perform microbiological assays for routine testing and qualification/validation of new methods. Support product method improvements and troubleshooting for assays as needed. Recognize atypical or out-of-specifications test results, instrument malfunctions and methodology problems and lead the investigation to resolve and correct. Support instrument validation activities. Accountable for the accuracy and validity of testing results. Review and validate data. Interpret results, perform or review mathematical calculations, and record observations using Laboratory notebooks or other controlled documentation. Ensure technical reports are prepared in a timely manner and review these reports for technical accuracy and compliance. Oversee maintenance of all related records and ensure that laboratory work area is maintained in a neat, orderly, and compliant manner. Identify activities to support team goals, contributing to overall project success and ensuring adherence to project timelines. Suggest continuous improvements to systems, procedures, etc. Carry out technical and administrative duties as needed.

Requirements

• BA/BS with at least 3 years of experience or MBA/MS with any years of experience
• Demonstrated cGMP experience in quality within the biotech or pharmaceutical industry
• Knowledge and practical application of relevant techniques – classical microbiology techniques
• Demonstrated ability to independently document and troubleshoot microbiological methods
• Excellent written and verbal communication and interpersonal skills
• Proficiency in laboratory information management systems and data analysis software
• Strong problem-solving skills and attention to detail

Nice To Haves

• Laboratory experience including novel rapid microbial technologies such as PCR or rapid bioburden
• Experience with technical writing, such as scientific reports, technical papers, method validation reports, etc.
• Familiarity with regulatory requirements and compliance standards
• Ability to work independently and as part of a team
• Strong organizational and time management skills
• Ability to adapt to changing priorities and work in a fast-paced environment
• 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

• Perform all work in compliance with cGMPs and site requirements.
• Perform microbiological assays for routine testing and qualification/validation of new methods.
• Support product method improvements and troubleshooting for assays as needed.
• Recognize atypical or out-of-specifications test results, instrument malfunctions and methodology problems and lead the investigation to resolve and correct.
• Support instrument validation activities.
• Accountable for the accuracy and validity of testing results.
• Review and validate data.
• Interpret results, perform or review mathematical calculations, and record observations using Laboratory notebooks or other controlled documentation.
• Ensure technical reports are prepared in a timely manner and review these reports for technical accuracy and compliance.
• Oversee maintenance of all related records and ensure that laboratory work area is maintained in a neat, orderly, and compliant manner.
• Identify activities to support team goals, contributing to overall project success and ensuring adherence to project timelines.
• Suggest continuous improvements to systems, procedures, etc.
• Carry out technical and administrative duties as needed.

Benefits

• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
• Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

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