QA Specialist

Eurofins USA Discovery Services; Fremont (CA); On-site; USD 73,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Discovery Services is seeking a Quality Assurance Specialist to implement and maintain the quality management system in a GMP/GxP environment. You will assure programs meet regulatory requirements and internal SOPs while supporting training and document control.

Responsibilities include maintaining the quality system, performing audits, supporting client inquiries, and contributing to study file preparation during audits and inspections.

Qualifications

• Bachelor’s Degree in a biological science related field, or equivalent work background.
• Minimum 1 year QA experience.
• Minimum 2 years work experience.

Responsibilities

• Maintain Quality Management system and ensure compliance with SOPs.
• Perform document control activities and update SOPs, forms, and presentations.
• Support training programs and create training files.
• Provide training sessions and scribe meeting minutes.
• Follow up on CAPA and Change Control systems.
• Conduct internal audits and prepare audit reports as needed.
• Assist with study files for client audits and regulatory inspections.
• Participate in multi-disciplinary meetings to provide status updates.
• Become a subject matter expert in a quality system as needed.
• Conduct QA reviews of study data and generate QA statements for reports.

Skills

Follow instructions

Independent worker

Understand QA processes

Document writing

Client communication

Instruction interpretation

Education

Bachelor’s Degree in biological sciences

Job description

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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It 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 Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer 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 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

The Quality Assurance Specialist is responsible, as a member of the Quality Assurance Unit (QAU), for implementing and maintaining the quality management system. The QA Specialist will assure that the quality assurance programs are maintained in accordance to pertinent regulatory requirements and internal SOPs in the performance of the duties of this position.

Here's what you'll do:

• 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 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.
• 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.
• Conduct QA reviews of study data generated when required.
• Generate QA statements for study reports when required

Qualifications

The ideal candidate:

• 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.
• Bachelor’s Degree in a biological science related field, or equivalent work background
• Minimum 1 year QA experience
• Minimum 2 years work experience
• Previous laboratory experience preferred.
• Previous experience with cell culture preferred.
• Previous experience within GxP/regulated environment preferred.

Additional Information

The position is full-time, Monday-Friday, 8 a.m.- 5 p.m., with overtime as needed. Candidates within a commutable distance of Fremont, CA are encouraged to apply.

Salary range: $73,000 - $90,000/yr.

• 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 USA Discovery Services is a Disabled and Veteran Equal Employment Opportunity employer.