
Bioassay Data Review Specialist
Required skills
- cGMP
- FDA regulated
- bioassay
- ligand-binding ELISA
- data verification
- investigations
- regulatory inspections
- life science
- chemistry
- biology
Role summary
Eurofins Scientific is seeking a Bioassay Data Review Specialist to join their team in Indianapolis, IN. This full-time role involves performing data verification, troubleshooting issues, and supporting bioassays within a cGMP environment. The position requires a Bachelor's degree in a life science field with 2-4 years of experience or a Master's degree with up to 2 years of experience. Key responsibilities include ensuring cGMP compliance, collaborating with cross-functional teams, and supporting regulatory inspections. Strong scientific, organizational, and communication skills are essential.
Responsibilities include but are not limited to:
- 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
- Bachelor’s degree in life science concentration (chemistry, biology, or related fields) and 2 to 4 years of directly related industry experience or a 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
- Position is full-time, working Monday-Friday 8:00 a.m.-5:00p.m overtime as needed
- Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply.
- 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
- Authorization to work in the United States indefinitely without restriction or sponsorship
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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.
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