Senior Scientist
- Full-time
Company 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.
Job Description
- Applies cGMP in all areas of responsibilities
- Writes, reviews, approves, or directs the preparation and approval of all Standard Operating Procedures (SOP), and manufacturing batch records
- Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system
- Reviews and approves a variety of methodologies as applied to various stages of pharmaceutical development
- Assigns appropriate QA staff to review data packages and manufacturing batch records and documentation
- Coordinates QA projects workflow to meet site goals turnaround time
- Follows and facilitates site adherence to establish quality compliance measures and respective regulatory agencies, including FDA and EU GMPs
- Performs all functions in support of and in compliance with all state and federal employment regulations
- Manages and directs QA and Document control functions
- Hosts and supports regulatory and client audits
- Reviews and approves the Corrective Action and Preventive Action (CAPA) program.
- Coordinates and directs the vendor approval and internal audit programs
- Discusses compliance issues with responsible scientist, Project Director, or Area Management
- Assigns QA staff in training new employees
- Monitors and approves employees’ time worked through time-entry system
- Prepares and presents site metrics during Senior Management review
- Supports new quality initiatives and continuous improvements
- Supports LEAN Projects
Qualifications
- Bachelors or Master’s degree in chemistry, biochemistry, biology, or one of the physical sciences
- 3-5 years of previous direct laboratory experience
- Preferred 1-2 years of experience with GMP pharmaceutical auditing experience
- 1-2 years of managing direct reports preferred
- Experience with cGMP, GLP, ICH, EMA, and USP regulations
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.
Position Salary Range- $80,000- 130,000 (based on experience, education)
- 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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