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 Overview:

The Quality Assurance Group Leader will supervise a team of PSS employees as well as participate in assuring that starting materials, products, processes, facilities, documentation and systems conform quality standards and governmental regulations. Additional responsibility includes assuring compliance with the regulations, procedures, and systems that govern the review of product release and the release of Active Pharmaceutical Ingredient. Additionally, this position is expected to identify potential problems with respect to compliance, production or testing activities and to work with the affected departments to resolve the issues. This position supports client and regulatory audits and is able to react to change productively and handle other essential tasks as assigned.

Position Requirements:

• Leads compliance review on the following records: batch record (includes on-the-floor review of records) and associated forms, in-process data, and applicable logs.
• Writes, reviews, and approves new and revised Standard Operating Procedures, Master Batch Records and Solution Records
• Works directly with manufacturing and other non-lab related departments responsible for GMP activities to resolve and/or approve deviations and other compliance issues in a timely manner. Interfaces directly with clients to provide updates and resolve issues.
• Review and approve deviation investigations.
• Review and approve change controls.
• Supports client and regulatory audits.
• Able to react to change productively and handle other essential tasks as assigned.
• Supervising other team members

Basic Minimum Qualifications:

• BS/BA plus 6 years’ experience or Masters degree and 4 years’ experience in a cGMP QA environment or equivalent is required.
• Inter and intra departmental project management experience, manufacturing operations experience, and experience with electronic document management systems are preferred.
• The ability to gown with plant uniforms and Grade C/ISO 7/Class 10,000 gowns is a must. Walking throughout the facility is required. Sitting for long durations may occur.
• Willingness to work 10 hour shifts for 4 times a week is required. Day and Night Shift and weekend work may be needed depending on business needs.
• Must have at least a year of leadership experience.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Position is full-time and permanent. Candidates currently living in a commutable distance to The Woodlands, TX are encouraged to apply.

What we offer:

• 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
• Yearly goal-based bonus & eligibility for merit-based increases

Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.