GMP Microbiology Lab Analyst

Eurofins PSS Insourcing Solutions; New London (CT); On-site; USD 52,000 - 78,000; Full time

Job summary

Eurofins USA PSS Insourcing Solutions in Groton, CT is seeking a detail-oriented analytical associate to support microbiological testing and GMP operations. The role involves performing TVC, appearance, coliform and other microbial tests in a GLP/GMP environment and maintaining rigorous documentation.

You will work with HPLC, Raman and FTIR, and utilize eLN and LIMS systems for data trending and release testing, collaborating with a team to ensure quality and compliance across development stages.

Qualifications

• Bachelor’s degree in science or related field or equivalent experience.
• Strong computer, scientific, and organizational skills.
• Experience with eLN, LIMS, and data trending.
• Excellent communication (oral and written) and attention to detail.
• Ability to work independently and as part of a team, self-motivated, adaptable, and positive.
• Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with policies.

Responsibilities

• Support analytical & microbiological testing and lab operations in a GMP environment.
• Perform TVC, appearance, Coliform and Choline microbial testing and GMP analytical testing.
• Maintain documentation and safety practices in GLP/GMP settings.
• Utilize analytical methodologies and systems to support GMP release and stability testing of clinical supplies.
• Analytical testing includes compendial testing, disintegration, dissolution, HPLC/UPLC, and related methods.
• Set up and analyze drug substance and drug product stability samples.
• Method development and validation of analytical methods for drug substances and products.

Skills

Computer skills

Scientific knowledge

Organizational skills

eLN & LIMS

Data trending

Communication

Teamwork

Self-motivation

Education

Bachelor’s degree in science

Tools

HPLC

Raman

FTIR

eLN

LIMS

Job description

Eurofins USA PSS Insourcing Solutions in Groton, CT is seeking a detail-oriented analytical associate to support microbiological testing and GMP operations. The role involves performing TVC, appearance, coliform and other microbial tests in a GLP/GMP environment and maintaining rigorous documentation.

You will work with HPLC, Raman and FTIR, and utilize eLN and LIMS systems for data trending and release testing, collaborating with a team to ensure quality and compliance across development stages.