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.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation 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 Organisations. It also has a rapidly developing presence in highly specialised 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 decentralised 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 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Become your most extraordinary self! Our team is intensely proud to be a major provider of services and products to the drug discovery research industry. Join Eurofins DiscoverX part of the Eurofins Discovery ™ group of companies serving global clients in the Pharma and Biotech industries. Work alongside industry experts and collaborate with team members to directly and positively impact human health worldwide!

We have a philosophy to support work life balance, career progression opportunities and offer many benefits such as formal mentoring programs, tuition reimbursement, extensive career training programs, competitive health benefits, paid time off and 10 annual paid holidays*.

Position Summary:

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.

Essential Duties and Responsibilities:

The primary responsibilities include, but are not limited to the following:

General

• 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

Job Specific

• 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.
• 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.

Basic Minimum Qualifications (BMQ):

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.

• 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.

Education/Experience (BMQ):

Bachelor’s Degree in a biological science related field, or equivalent work background

Minimum 1 year QA experience

Minimum 2 years work experience

Additional preferences:

Previous laboratory experience preferred.

Previous experience with cell culture preferred.

Previous experience within GxP/regulated environment preferred.

Ability and/or Skills (BMQ):

Attention to detail.

Organized.

Other Factors:

Occasional evening and/or weekend work may be required at certain times of the year.

Compensation range: $65,000.00 - $90,000.00/ year

Disclaimer:

This position description is written as a guideline to inform employees of what is generally expected of them at each job level. The description is not intended to be all encompassing or limiting in any manner; rather, it is hoped it will add understanding and better reflect the work performed at all levels of employment. Duties and responsibilities other than those listed may be included as needed within the work group or the company as a whole.

The above information may not be used or duplicated by others without written consent.