QC Analyst II

Meet Life Sciences; Watertown (MA); On-site; USD 75,000 - 110,000; Full time

Job summary

Meet Life Sciences is seeking a QC Analyst II focused on Environmental Monitoring (EM) to support GMP manufacturing operations. You will perform EM sampling, review data, and help maintain data integrity across QA and Manufacturing teams.

Ideal candidates have 3+ years in a GMP QC lab with EM experience, strong microbiology skills, and a proven track record in documentation and problem solving. CDMO/CMO experience is a plus.

Qualifications

• 3+ years of experience in a GMP Quality Control laboratory.
• Hands-on Environmental Monitoring experience in a GMP manufacturing environment.
• Experience with microbiological techniques and environmental monitoring programmes.
• Excellent documentation practices and commitment to data integrity.
• CDMO/CMO experience is highly desirable.

Responsibilities

• Perform routine Environmental Monitoring sampling and testing in GMP manufacturing areas.
• Review EM results, analyze trends, and generate monitoring reports.
• Record, review, and maintain laboratory data per cGMP and GDP requirements.
• Collaborate with Manufacturing, QA, Development, and Project Management teams.
• Assist with investigations, deviations, and continuous improvement initiatives.

Skills

EM experience

GMP QC

Data integrity

Documentation

Problem solving

Prioritization

Communication

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences/Biology/Microbiology or related field

Job description

We are looking for a QC Analyst II – Environmental Monitoring (EM) to join a growing Quality Control team supporting GMP manufacturing operations. This role will primarily focus on Environmental Monitoring (EM) activities, ensuring manufacturing environments meet the highest standards of quality and regulatory compliance.

Working within a fast-paced CDMO environment, you will perform environmental monitoring, review data and trends, support laboratory investigations, and collaborate closely with Manufacturing, Quality Assurance, and Development teams. This is an excellent opportunity for someone with a strong microbiology or environmental monitoring background looking to further their career in Quality Control.

Key Responsibilities

• Perform routine Environmental Monitoring (EM) sampling and testing throughout GMP manufacturing areas.
• Review EM results, analyse trends, and generate monitoring reports.
• Perform growth promotion testing of microbiological media.
• Conduct sampling and testing of Water for Injection (WFI) and clean steam systems.
• Support raw material testing activities as required.
• Record, review, and maintain laboratory data in accordance with cGMP and GDP requirements.
• Participate in laboratory investigations, including deviations and Out of Specification (OOS) events.
• Assist with troubleshooting laboratory issues and support continuous improvement initiatives.
• Author and revise SOPs, test methods, protocols, reports, and other controlled documentation.
• Collaborate with Manufacturing, Quality Assurance, Development, and Project Management teams.
• Communicate testing results, quality issues, and project updates effectively to key stakeholders.
• Maintain accurate laboratory documentation and ensure compliance with quality systems.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific discipline.
• 3+ years of experience in a GMP Quality Control laboratory.
• Hands-on experience performing Environmental Monitoring within a GMP manufacturing environment.
• Experience with microbiological techniques and environmental monitoring programmes.
• Strong understanding of cGMP, GDP, and quality system requirements.
• Experience supporting laboratory investigations, deviations, and continuous improvement initiatives.
• Previous experience within a CDMO/CMO environment is highly desirable.
• Excellent documentation practices and commitment to data integrity.
• Strong problem-solving, analytical, and organisational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong written and verbal communication skills.