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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. 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.

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

The Quality Assurance Specialist is responsible for implementing and maintaining the quality management system. The QA Specialist will assure that the quality assurance programs for the screening service sites in San Diego and Fremont, CA are implemented and maintained in accordance to pertinent regulatory requirements and internal SOPs in the performance of the duties of this position.

• Implement and maintain the Quality Management system
• Perform document control activities.
• 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.
• Support the training program, such as creating training files and ensuring that they are updated and current as appropriate.
• Provide training sessions.
• Host audits, manage the meetings and/or scribe meeting minutes.
• Follow up on CAPA and Change Control systems, as appropriate.
• Perform 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.
• 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.
• Ability 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.
• Ability to conduct QA reviews of study data generated when required.
• Ability to 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
• 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

For all Eurofins Discovery Services Businesses in US; Successful applicants will be required to confirm vaccination status or demonstrate eligibility for medical or religious exemptions prior to commencing employment.

The Ideal Candidate would posses:

• 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.
• Previous laboratory experience 
• Previous experience with cell culture
• Previous experience within GxP/regulated environment

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
• Authorized to work in the country for any employer indefinitely without sponsorship

• 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.