GMP Bioassay Data Reviewer & ELISA QC Specialist

Eurofins; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life and Disability Insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a life sciences professional for a full-time position in the United States. Responsibilities include data verification, performing cell culture and bioassays in a GMP environment, and collaborating across teams to address quality events.

The role requires a Bachelor's or MS in life sciences and experience in cGMP/FDA-regulated labs, strong communication, and detail-oriented problem solving.

Qualifications

• Bachelor’s degree in life science concentration (chemistry, biology, or related fields) and 2 to 4 years of directly related industry experience or an MS degree in a life science concentration (chemistry, biology, or related fields) and up to 2 years of directly related industry experience.
• Proficiency in cGMP and FDA regulated clinical services laboratory environment
• Strong computer, scientific, and organizational skills
• Excellent written and oral communication with attention to detail
• Capability to work well on a team and be able to troubleshoot and problem solve in cross functional team setting

Responsibilities

• Perform verification of data and confirm resolution of issues identified
• Perform cell culture, cell-based bioassay, and surrogate bioassays such as ligand-binding ELISA assays in plate-based formats in a GMP environment and other lab tasks for training and as needed.
• Anticipate quality events or issues and elevate them to appropriate management attention immediately
• Independently engage and collaborate with coworkers, customers, and management within a cGMP environment
• Must be able to identify problems and know when to solve proactively and seek advice
• Contribute and participate in investigations, as needed
• Support regulatory and client inspections, as needed

Skills

cGMP experience

Data verification

Analytical skills

Teamwork

Communication skills

Attention to detail

Education

Bachelor's in life sciences

MS in life sciences

Job description

Eurofins USA PSS Insourcing Solutions is seeking a life sciences professional for a full-time position in the United States. Responsibilities include data verification, performing cell culture and bioassays in a GMP environment, and collaborating across teams to address quality events.

The role requires a Bachelor's or MS in life sciences and experience in cGMP/FDA-regulated labs, strong communication, and detail-oriented problem solving.