Quality Assurance Manager

Eurofins Lancaster Laboratories   •  

Terre Haute, IN

Industry: Business Services

  •  

Less than 5 years

Posted 296 days ago

This job is no longer available.

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

· Ensure quality and compliance of Amatsigroup Inc sponsored non-clinical and clinical trials

· Adhere to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific, and current industry standards and practices)

· Support the team on ensuring GLP studies are conducted in a compliant manner

· Write and review SOPs and version controlled Forms

· Train employees on GLP requirements

· Perform internal audit of the Facility and of the Studies performed on site (study plan, raw data, report as well as critical phases)

· Perform external audit (sub-contractors)

· Manage the Regulatory Agencies audits and/or Sponsor audits performed on site and prepare a Corrective Action and Preventive Action Plan

· Lead team, schedule, and train employees

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

· Ensure coverage and performance

· Foster morale and teamwork

The ideal candidate would possess :

· 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 work with minimal supervision

· 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 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)

· Min 3 years of hands on GLP experience a must

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

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