GMP Investigation Specialist- Group Lead

Company Description

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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

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

Technical Responsibilities

• Ability to work independently and as part of a team in a client facing environment.
• Self-motivated, adaptable, and a positive attitude
• Excellent communication (oral and written) and attention to detail
• Independently investigating non conformances and preventing reoccurrences in support of manufacturing operations
• Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances
• Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
• Communicating findings and recommendations at group meetings
• Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
• Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
• Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes
• Participating in and/or leading cross-functional study teams to get results, support and or author investigations
• Gathering, trending, and analyzing process related data to drive consistency and timeliness
• Documenting all training
• Training new employees on investigative processes and techniques
• Coordinating and/or leading cross-functional meetings with multiple departments.

Leadership Responsibilities

• Leading direct reports, group leaders and their teams, and serving clients in technical settings, such as laboratories or manufacturing facilities
• Demonstrate and promote the company vision
• Proactively plan and multitask to maximize productivity
• Coordinate all quality and productivity metrics, and demonstrate strong teamwork and collaboration
• Support coordination of scheduling & allocation of responsibilities, and new hire on-boarding process
• Coordinates training program
• Monitors the day to day operations of QC analyst staff
• Development of teambuilding strategies and initiatives
• Application of Lean concepts to improve operational excellence
• Participating with candidate interviews
• Performs peer review of data.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, or related field. Other degrees may be considered with relevant experience.
• 3+ years of experience in a Pharmaceutical GMP setting required
• QA/Investigations experience preferred
• 3-5 years of previous dynamic team leadership experience
• Understanding of biologics manufacturing operations
• Are organized and have an attention to detail
• Can prioritize multiple assignments and changing priorities
• Ability to learn and utilize computerized systems for daily performance of tasks

Additional Information

Minimum 3 years leadership experience required to be considered

The position is full-time, Monday-Friday 8am-4:30pm.