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Senior Quality Assurance Associate - job 1 of 2

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 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 2023, 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 Senior Quality Assurance Associate is responsible for administrative function, data reporting, document control, equipment control, auditing, regulatory compliance, stability, and manufacturing activities as needed.

Start and stop work authority
Supports admininistration function by:
- Acting as the Deputy QAS/QAM in their absence
- Monitoring quality systems deadlines and reports to management pending and overdue activities
- Assisting with the PO system for the QA group o maintaining Analytical Subcontractor compliance
- Writing, reviewing, and approving Events, CAPA, OOS/OOT and Change Control
- Managing investigations
- Writing, reviewing, and conducting Quality System, cGMP, and GLP training
- Participating in data analysis and reporting
- Serving as QA trainer, as needed
Supporting sister sites(s) as required
- Supports all Quality Assurance I and II roles for:
- Auditing
- Data reporting
- Document control
- Equipment control
- Manufacturing (as required)
- Stability (as required)
Supports Auditing by:
- Performing Internal audits per Standard Operating Procedure
- Supporting and hosting client and regulatory audits
- Conducting external audits
Supports Regulatory Compliance
Supports the Stability Program as needed by:
- Reviewing and approving Stability Protocols
- Reviewing Stability Chamber Pull Schedules
- Reviewing and approving Stability Chamber mapping o monitoring and following up Stability Chamber excursions o other task as required
Supports Manufacturing as needed by:
- Executing and reviewing batch records
- Quality assurance inspection and release of cGMP materials o reviewing, creating, and approving Batch Records
- Reviewing, creating, and approving Certificates of Compliance
- Conducting cGMP vendor qualification
Other functions as assigned

Qualifications

Basic Minimum Qualifications:

10+ years in a GMP/GLP environment with 7+ years in a QA role
- Or 5 years of similar experience plus a Bachelor's Degree in a scientific field
Minimum of an Associate’s Degree
Understanding of FDA requirements and Quality Systems
Must have good administrative skills (Microsoft Office Suite, LIMS, QMS)
Ability to work in the US, for any company, indefinitely, without sponsorship

Additional Information

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

Eurofins Glassdoor Company Review

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Average salary estimate

$90000 / YEARLY (est.)

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$80000K

$100000K

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What You Should Know About Senior Quality Assurance Associate, Eurofins

Are you ready to elevate your career with Eurofins Scientific as a Senior Quality Assurance Associate in Cary, NC? This role is all about ensuring the highest standards of safety and compliance in the analytical testing services we provide across diverse industries. At Eurofins, we take pride in our expansive global presence and our mission to make life and the environment safer and healthier. As a Senior Quality Assurance Associate, you'll dive into a variety of responsibilities such as administrative functions, data reporting, and document control. You will play a crucial role in supporting the Quality Assurance team, which includes acting as the Deputy QAS/QAM when necessary and monitoring quality systems to ensure that deadlines are met. Your expertise will be key in managing investigations, writing and reviewing quality system documents, and conducting training sessions that uphold our commitment to cGMP and GLP standards. Moreover, you will be responsible for conducting internal audits and supporting regulatory compliance through various essential tasks. With over a decade of experience in a GMP/GLP environment, you will bring deep knowledge of FDA requirements and Quality Systems, helping us maintain our reputation as a global leader in the analytical testing field. If you have a robust background in quality assurance, administrative skills, and a knack for detail, we'd love to have you on our team. Join us in Cary, NC, and contribute to making a lasting impact on industries you care about!

Frequently Asked Questions (FAQs) for Senior Quality Assurance Associate Role at Eurofins

What are the key responsibilities of a Senior Quality Assurance Associate at Eurofins Scientific?

As a Senior Quality Assurance Associate at Eurofins Scientific, your key responsibilities include managing administrative functions, ensuring regulatory compliance, writing and reviewing key quality documents, conducting internal audits, and supporting the quality assurance team across various tasks. You'll also play a pivotal role in training staff on quality systems, managing investigations, and executing batch records.