GMP Compliance Specialist Job at Eurofins USA PSS Insourcing Solutions
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.
Applies GMP/GLP in all areas of responsibility, as appropriate.
- Independently engage and collaborate with coworkers, customers, and management within a GMP environment
- Work with multiple analytical testing group in a GMP environment to harmonize cGMP operations with the goal of minimizing departures, deviation observations, and deviations
- Ensure adherence to highest quality and efficiency standards in laboratory operations
- Anticipate quality events or issues and elevate them to the appropriate management immediately
- Participate in conducting and assisting with investigations, writing quality events, and putting effective CAPAs in place
- Help develop and manage an internal walkthrough system
- Conduct walkthroughs of lab spaces to support client and regulatory inspection readiness
- Assist with training oversight
- Help develop and lead training session for our staff
- Help maintain a compliance SharePoint site
- The compliance program is under continuous development and additional project and job responsibilities could be added in the future as the program evolves.
The Ideal Candidate would possess:
- Excellent communication (oral and written) and attention to detail
- Proficient with technical writing in cGMP and FDA regulated clinical services laboratory environment
- Ability to work independently, self-motivation, adaptability, and a positive attitude
- Ability to learn new principles, read and comprehend complex subjects, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Experience performing root cause analysis
- Strong computer, scientific, and organizational skills
Minimum Qualifications:
- Bachelor’s or M.S. degree in a life science concentration (chemistry, biology, or related fields) with related industry experience (4+ years for B.Sc. candidates and 2+ years for M.S. candidates) (two years of directly related industry experience is equivalent to one full-time year of college in related major)
- At least 3 years related GMP pharmaceutical experience in either operations/testing role or as part of a QA team
Additional Information
Position is full-time, Monday- Friday 8 am-5 pm- May be requested to work on weekends, overtime, and holidays based on business needs.
- 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
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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