Manager - Quality Engineering

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 labeling 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 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins BioPharma Product Testing-Columbia has delivered expert scientific support to companies working to improve human and animal health. As a member of the Eurofins BPT Columbia team, you’ll work alongside respected technical experts dedicated to scientific excellence in a process driven regulatory compliant environment.  

Job Description

Overseeing all managerial and technical operations of quality engineering department; providing leadership and coaching to assigned individuals; participating in long- and short-term planning and goal setting for group; operating department in a safe, efficient, and quality-oriented manner according to annual budget predictions; ensuring department is compliant according to current GLP/GMP regulations. 

Essential Duties and Responsibilities:

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Demonstrates and promotes the company vision
• Regular attendance and punctuality
• Applies the highest quality standard in all areas of responsibility
• Demonstrates strong client service skills, teamwork, and collaboration
• Proactively plans and multitasks to maximize productivity
•  Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
• Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system; ensure that corrective action is appropriate; ensure that follow up requirements are completed
• Write SOPs and qualifications, perform new systems investigation, address clients' technical questions, troubleshoot systems, and oversee work flow in departments
• Review data and documents according to departmental, corporate, and regulatory procedures; make sure all work is performed according to GMP requirements
• Assist staff with administration of quality engineering programs; oversee quality engineering projects including research, installation, appropriate documentation, and development of testing protocols for new instrumentation and technology
• Oversee and manage technical and administration aspects of enterprise quality software systems (e.g. EMS, Empower)
• Attend meetings for lab, share appropriate information with staff, process various paperwork needed by support groups (i.e. vacation, schedules, etc.)
• Interview and recommend for hire new personnel, maintain up-to-date job plans, performance and promotion reviews, and handle personnel issues
• Handle client audits, phone calls, letters to clients, client visits, and attendance at some local and national meetings
• Enable and equip staff to do work, provide and recommend training
• Stay technologically current, investigate new technology and instrumentation; act as a technical resource for internal problems and projects; stay current with regulatory requirements; interpret regulations and coordinate implementation of new internal programs and procedures
• Development of budget, monitor expenses, look for cost-saving applications; provide routine departmental business review updates to executive management
• Perform all functions in support of and in compliance with all state and federal employment regulations
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned

Qualifications

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.

Ten years within the bio/pharmaceutical industry including experience with laboratory software and/or instrumentation; Regulatory experience including quality system/program development required;