Bioassay Data Review Specialist

Eurofins PSS Insourcing Solutions; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Paid vacation and holidays

Life and disability insurance

Job summary

Eurofins USA PSS Insourcing Solutions seeks a quality-focused professional to apply GMP/GLP in all areas of responsibility. You will verify data, anticipate issues, and coordinate with management in a cGMP setting.

The role emphasizes analytical rigor, cross-functional teamwork, and readiness to support inspections and investigations as needed. A biology/biochemistry/chemistry background is required.

Qualifications

• 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.
• Ability to read, comprehend, and present complex subjects.

Responsibilities

• Perform verification of data and confirm resolution of issues identified.
• 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

FDA-regulated environment

communication

team collaboration

problem solving

computer skills

Education

Bachelor's degree in biology/biochemistry/chemistry

Job description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Applies GMP/GLP in all areas of responsibility, as appropriate.

• Perform verification of data and confirm resolution of issues identified
• 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

Qualifications

• 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
• Ability to read, comprehend, and present complex subjects

Minimum Qualifications:

• Bachelor's degree in biology, biochemistry, chemistry, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
• At least 3 years of related GMP pharmaceutical experience in either an operations or testing role
• Authorization to work in the United States indefinitely without restriction or sponsorship
• Ensure adherence to highest quality and efficiency standards in laboratory operations
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

• Position is full-time, working Monday-Friday 8:00 a.m.-5:00p.m overtime as needed
• Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.