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Quality Assurance Group Leader

Eurofins USA BioPharma Services

Quality Assurance Group Leader

San Diego, CA
Full Time
Paid
  • Responsibilities

    Job Description

    • Apply GMP in all areas of responsibilities, as appropriate. 
    • Support, perform, and promote all QA functions in compliance with quality policy and regulatory requirements. 
    • Follow and facilitate adherence to establish quality compliance measures and respective regulatory agencies, including FDA and EU GMPs. 
    • 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. 
    • Develop and implement operational improvements. 
    • Coach, train, and develop others within the group with respect to their personal development and effective implementation of operational improvements. 
    • Coordinate workflow and perform daily monitoring to meet project turnaround times. 
    • Conduct performance reviews, interview applicants, keep training records up to date for assigned employees. 
    • Confront and address problems, concerns, and performance issues.
    • Reviews scientific projects for compliance adherence to internal and external quality regulations
    • Discusses compliance issues (deviations, out of specification, CAPAs) with responsible scientist, Project Director, or Area Management
    • Writes, formats, trains on Standard Operating Procedures
    • Supports internal and external Quality Audits
  • Qualifications

    Qualifications

    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 learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
    • Solid understanding of chemistry/lab practices.
    • Knowledge of auditing techniques.
    • Familiarity with at least one scientific technique (HPLC, GC, etc.)
    • Previous leadership experience is a plus

    MINIMUM QUALIFICATIONS:

    • Bachelor’s or Master’s degree in Chemistry or closely related science field from a four year college/university or equivalent education and job experience
    • Authorization to work in the United States indefinitely without restriction or sponsorship
    • Minimum of five years of bio/pharmaceutical chemistry/microbiology experience with some data review responsibilities and a working knowledge of regulatory requirements

    Additional Information

    Position is full-time, Monday - Friday 8:00am - 5:00pm.  Candidates currently living within a commutable distance of San Diego, CA 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 EQUAL EMPLOYMENT OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.