Process Data Assistant

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

Summary: Supports lifecycle management within the QC Technical Resources groups. Utilizes and applies scientific knowledge and techniques to complete change controls, corrective actions, protocols and reports for transfers, validations and method performance

• Analyzes and Monitors day-to-day method performance in QC lab, including determining if problem resolution requires appropriate subject matter expert to help with any method-related issues.

• Works directly with Regulatory Sciences and External Manufacturing and partners and communicates timelines for method validation/transfers to managers in QC Tech Resources.

• Communicates method updates to partners and tracks progress of updates.

• Analyzes, assembles and/or coordinates method performance reports and quality metrics.

• Implements multi-site method harmonization and reviews of method performance.

• Participates in and coordinates post-transfer investigations between contract sites and collaborative partners.

• Tracks team activities and timelines to ensure that the deliverables within the project plans are met and on time.

• Escalates issues to management, as needed.

• Coordinates multi-site trending and reviews and communicates information to SMEs, as needed.

• Continuously drives to improve processes for improved performance.

• Performs and/or coordinates assay qualification for the QC Group.

• Drafts new or updated test procedures and assays for QC Group.

• Performs and/or coordinates assay transfers from R&D, internally within QC or to business partners.

• Authors and/or coordinates technical document preparation.

• Owns and coordinates change controls and corrective/preventative actions

• Participates in training programs for QC personnel.

Qualifications

Education and Experience:

Requires BS/BA in a Life Sciences field or equivalent combination of education and experience.

Knowledge, Skills and Abilities:

• Ability to work independently or as part of a team.
• Ability to communicate with transparency.
• Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint).
• Skilled at gathering and organizing information.
• Ability to follow directions and perform well-defined tasks.
• Effective time management skills.
• Excellent written and oral communication skills.
• Ability to develop strategy and create metrics to measure effectiveness of strategy.
• Ability to identify and effectively communicate risks.
• GMP experience preferred

Additional Information

Position is full-time, Mon-Fri 8am-4:30pm. Candidates currently living within a commutable distance of Rensselaer, NY 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 Equ