Scientific QA Specialist | Eurofins

  • Fremont, CA, USA
  • Full-time

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 labelling 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 over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

 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.

Job Description

  • Adheres to site employee health and safety (EHS) requirements
  • Maintain current training status in the areas of responsibility
  • Ensure the work performed follows internal or client specified procedures
  • Maintain the Quality Management system
  • Provide quality support in writing, reviewing, revising, and maintaining standard operating procedures (SOPs), forms, presentations, and other business documents.
  • Assure documents capture the current process, provide sufficient detail to perform the process, and comply with internal procedures for generating documents.
  • Perform document control activities.
  • Support the training program, such as creating training files and ensuring that they are updated and current as appropriate.
  • Provide training sessions.
  • Host meetings and/or scribe meeting minutes.
  • Assist in managing the CAPA and Change Control systems.
  • Assist with internal audits to ensure compliance is maintained within the organization. May provide audit reports to the applicable audited function/area management.
  • Cooperate in the preparation of study files prior to and during all client audits and regulatory inspections.
  • May be assigned to attend meetings and participate on multi-disciplinary teams, as required, to provide routine status updates related to their functional area and/or to provide quality guidance.
  • May be assigned to become a subject matter expert (SME) in a particular quality system (i.e. documentation, supplier quality, other) depending on experience, skill set, and business needs.
  • May conduct QA reviews of study data generated when required.
  • May generate QA statements for study reports when required.
  • Demonstrates and promotes the company vision
  • Regular attendance and punctuality
  • Conducts all activities in a safe and efficient manner
  • Performs other duties as assigned
  • Owns the accountability and responsibility of delivering to client needs and timeliness
  • Provides cross-functional support to other departments as required
  • Adjusts work hours as needed to meet deadlines

Qualifications

The Ideal Candidate would possess:

  • Previous laboratory experience
  • Previous experience with cell culture
  • Previous experience within GxP/regulated environment
  • Ability to follow instructions and deliver complete and accurate results.
  • Ability to perform tasks independently, and as team player.
  • Ability to read and understand common Quality Assurance processes.
  • Ability to write and interpret documents such as standard operating procedures.
  • Ability to speak effectively and professionally with internal colleagues as well as with clients when needed.
  • Ability to construct, communicate, and interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Basic Minimum Qualifications: 

  • Bachelor’s Degree in a biological science related field, or equivalent work background
  • Minimum 1 year QA experience
  • Minimum 2 years work experience
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

Position is full-time, Monday – Friday 8:00am – 5:00pm.  Candidates currently living within a commutable distance of Fremont, 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.

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