Pharmaceutical Change Control Specialist

Pharmaceutical Change Control Specialist

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

Position Responsibilities:

• Providing analytical change management for biochemistry, chemistry, virology, and supplies inspection testing labs
• Ensuring compliance in the laboratory in accordance with cGMPs, GLPs, regulation, and policies/procedures
• Coordination of all analytical change activities in the laboratories
• Support key commitments for analytical change within laboratory operations aimed at elevating compliance, efficiency, assay robustness, and performance of the laboratories

Qualifications

Basic Minimum Qualifications:

• BS or MS in the life sciences with at least 5 years change control/project management experience and previous GMP experience necessary
• Must be legally eligible to work in the United States indefinitely without restriction or sponsorship

The ideal candidate would possess:

• Project management, change execution management and team leadership experience in a quality function
• Proven ability to manage multiple projects/tasks simultaneously
• Working knowledge of general laboratory skills and techniques
• Demonstrated self-starter with capability to develop innovative solutions to challenges
• Excellent communication skills, oral and written
• Strong organization and attention to detail
• Ability to learn new techniques, keep accurate GMP records, follow instructions, and comply with company policies
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Biochemistry/chemistry/virology lab experience preferable

Additional Information

The position is full-time, first shift, Monday-Friday with overtime as needed. Candidates living within a commutable distance of West Point, PA 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 USA PSS Insourcing Solutions is a disabled and veteran equal employment opportunity employer.