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GMP Investigation Specialist Supervisor

Company: Eurofins PSS Insourcing Solutions
Location: Rensselaer
Posted on: January 16, 2022

Job 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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. 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.

In 2020, Eurofins generated total revenues of EUR --- 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Leadership Responsibilities
Leading direct reports, group leaders and their teams, and serving clients in technical settings, such as laboratories or manufacturing facilities
Disseminate administrative communications
Demonstrate and promote the company vision
Proactively plan and multitask to maximize productivity
Meet all quality and productivity metrics, and demonstrate strong teamwork and collaboration
Coordinate scheduling and allocation of responsibilities, and new hire on-boarding process
Coordinates training program
Development of teambuilding strategies and initiatives
Application of Lean concepts to improve operational excellence
Support group leader professional development
Coordinating and participating with candidate interviews
Performs peer review of data.

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.
Qualifications

The Ideal Candidate Would Possess
Scientific background with hands on laboratory experience
Strong leadership skills
A good understanding of day to day business operations
Demonstrate strong client service skills, teamwork, and collaboration
Strong computer, scientific, and organizational skills
Excellent communication (oral and written) and attention to detail
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Qualifications
Bachelor's degree in Life Sciences, Chemistry, or related field. Other degrees may be considered with relevant experience.
2+ years of experience in a cGMP setting
3+ 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

Position is full-time, 1st shift, Monday - Friday, 8:00am-4:30pm. Candidates currently living within a commutable distance of Rensselaer, NY and the surrounding areas 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.

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

Keywords: Eurofins PSS Insourcing Solutions, Albany , GMP Investigation Specialist Supervisor, Other , Rensselaer, New York

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