Quality Assurance Manager

Confidential Company  •  Winston Salem, NC

5 - 7 years experience  •  Tobacco

Salary depends on experience
Posted on 07/21/17 by Ashley Spangler
Winston Salem, NC
5 - 7 years experience
Tobacco
Salary depends on experience
Posted on 07/21/17 by Ashley Spangler

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 $2 billion in annual revenues and 25,000 employees across 250 sites in 39 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 Lancaster Laboratories PSS is searching for a Quality Assurance Manager in Winston Salem, NC.

Quality Assurance Manager responsibilities include, but are not limited to, the following :

· Perform all QA functions in compliance with quality policy and regulatory requirements

· Implement and manage compliant Quality Management Systems and Quality Operations to applicable requirements of cGMP, cGLP, and ISO/IEC 17025

· Manage and mentor the Quality Assurance personnel in accordance with vision, values, and strategic goals of the company

· Stay abreast of evolving regulatory or industry quality assurance requirements and provide guidance to management team on quality and regulatory topics

· Assist and/or prepare and present training programs required to satisfy regulatory requirements.

· Author and approve technical documents, standard operating procedures, protocols and reports

· Develop SOP’s and/or policy documents as needed to address new process or major changes to a process

· Host applicable regulatory audits and/or inspections

· Ensures data is accurate and quality control measures are adequate

· Oversee document change control procedures

· Lead team, schedule, and train employees in client environment

· Ensure adherence to highest quality and efficiency standards in laboratory operations

· Ensure coverage and performance

· Foster morale and teamwork

The ideal candidate would possess :

· Broad base of technical and operations expertise

· Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

· 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

· Strong leadership, initiative, and teambuilding skills

Basic Minimum Qualifications :

· Bachelor's degree in Regulatory Affairs, Chemistry, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)

· 5years relevant cGMP/GLP/ISO17025 knowledge and/or experience in a regulator

· Authorization to work in the United States indefinitely without restriction or sponsorship

Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed.  Candidates currently living within a commutable distance of Winston Salem, NC are encouraged to apply.

As a Eurofins Lancaster Labs 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.

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

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