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.
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 Panlabs, Inc.part of the Eurofins Discovery ™ group of companies serving 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. This position also has potential for remote working.
Under minimal supervision, 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.
- 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
QualificationsThe Ideal Candidate would possess:
- Manage, oversee and enhance the Quality Management system. Elevate areas of concern or for improvement, track items and drive to completion.
- 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 by creating/maintaining training files, training curricula, training modules and courses as needed.
- Prepare and provide training sessions for quality related topics.
- For Quality related topics, schedule, host and/or scribe for meetings.
- Follow up on CAPA and Change Control systems, as appropriate. Support investigation and ensure root cause analysis, assist in summary writing and review.
- Manage and coordinate internal audits to ensure compliance is maintained within the organization. Provide audit reports to the applicable audited function/area management.
- Coordinate and manage client audits and regulatory inspections for onsite actions and external communications and actions.
- Track, review and improve KPIs. Review and assess quality systems for compliance and trends, summarize and present to management as needed.
- Assure documents are securely saved as per Archival process, including conversion to electronic true copies, hardcopy records storage under QA control, and ultimate archival or destruction.
- 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 Requirements:
- 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 preferred.
- Previous experience with audit programs preferred.
- Previous experience within GxP/regulated environment preferred.
- Bachelor's Degree in a biological science related field, or equivalent work background
- Minimum 2 year QA experience
- Minimum 5 years work experience in a relevant field
- Authorization to work in the US for any employer, indefinitely, without sponsorship.
- For all Eurofins Discovery Services Businesses in US; Successful applicants will be required to confirm positive COVID-19 vaccination status or demonstrate eligibility for medical or religious exemptions prior to commencing employment.
Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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- 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