GMP Manufacturing QC Manager
Eurofins - Huntsville, AL
Eurofins is the world leader in the food, bio/pharmaceutical product testing. It is also number one in the field of environmental laboratory services and one of the global market leaders in agroscience, genomics, discovery pharmacology, and central laboratory services. With over $1 billion in annual revenues and 13,000 employees across 170 sites in 35 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the pharmaceutical, biopharmaceutical, food, environmental, and consumer products industries and to governments. Eurofins MWG Operon, Inc. is a leading provider of genomic services established around the core business lines of traditional and next generation DNA sequencing services as well as oligonucleotide and gene synthesis. The company is focused on customer convenience, speed of delivery and a high quality of service for life science companies and academic research institutions around the world. Eurofins is searching for a GMP Manufacturing QC Manager located in Huntsville, AL. Department: Quality Control

The GMP Manufacturing QC Manager receives sufficient authority from and is accountable to the Dir. Quality for the successful completion of assigned duties and responsibilities. The QC Manager is responsible for the final release of product, and for managing and coordinating all activities of the manufacturing QC department including personnel, work flow, and processes, and interactions with other departments within the company.

All Eurofins employees must keep a strong Customer Focus to promote and maintain Eurofins Core Values.

Responsibilities Include:
  • Effectively oversee and manage a high-throughput GMP manufacturing QC department
  • Interpret and report final results in accordance with company standard operating procedures, and GMP guidelines
  • Set priorities, identify and reduce backlogs and bottle necks and correct for deviation from established procedures.
  • Have the ability to evaluate data and independently solve problems
  • Help Technical Support troubleshoot customer enquiries, and participate in CAPA investigations
  • Identify projects geared towards improving quality, reducing costs, and improving turnaround time
  • Perform laboratory activities to support implementation of new equipment and/or methods and validation
  • Effectively manage personnel and material resources to ensure timely release of product
  • Maintain a high degree of personal initiative, interact positively with all manufacturing staff and management
  • Create and maintain a high performance team, including hiring, goal setting, disciplining and coaching
  • Successfully complete any required training and ensuring Quality Standards are maintained
  • Strictly adhere to company health, safety and regulatory policies
  • Be prepared to work on any shift or weekends if requested.
  • Keep sensitive information confidential and acting ethically in all circumstances.

Requirements:
  • Bachelor’s Degree, preferably in Chemistry
  • 3-5 year’s experience of GMP medical device, biotechnology, or chemistry QC department
  • Previous experience with analysis/purification by Mass Spec. Capillary Electrophoresis, PAGE or HPLC
  • Previous leadership/management experience and demonstrated ability to provide group leadership.
  • Ability to set priorities, manage multiple priority tasks and make decisions under time pressure
  • Ability to communicate clearly verbally and in writing
  • Ability to work with Hazardous Chemicals and to lift 35+ pounds
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Preferences:
  • Experience in an ISO- 9001 and/or 13485 environment
  • Previous experience with DNA/RNA manufacturing environment is preferred.
  • Previous training experience
  • Hazardous Waste Operations and Emergency Response (HAZWOPER) initial 24 hour training and annual 8 hour refresher training.
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options. To learn more about Eurofins, please explore our website www.eurofinsus.com . Eurofins is an Equal Employment Opportunity and Affirmative Action employer.

Eurofins - 30+ days ago - save job - block
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About this company
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Eurofins Scientific is the world leader in food and pharmaceutical products testing. It is also number one in the world in the field of...