Senior Quality Specialist
- Full-time
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.
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.
Job Description
- Initiate and lead root cause analysis investigations and implement corrective and preventive actions in a production analytical chemistry laboratory (smoke, analytical, and physicals testing).
- Prepare diagnostic actions plans to troubleshoot analytical system failures or trends in statistical process control data.
- Communicate to group leaders, lab manager & director in addition to client stakeholders laboratory status, issues impacting results delivery and quality, and raise risks and opportunities to quality in a timely manner
- Review laboratory data (smoke, analytical & physical) and assess quality control
- Monitor and assess statistical process control data and elevate trends or out of control events to management and client stakeholders
- Maintain, review, and submit all Trackwise records related to CAPAs and Events.
- Coordinate, schedule, and support internal and external audits, provide support for inspections, incidents, deviations, and CAPAs in accordance with current quality management system process.
- Consult on development of quality improvements and recommend solutions as applicable.
- Respond to internal audit observations within 30 days of report receipt identifying planned actions
- Write and revise SOPs and Work Instructions. Proactively recommend and participate in process improvement projects.
- Coordinate document control.
- Coordinate, schedule, and conduct internal audits; prepare for external audits; host external auditors
- Prepare for external audits; host external auditors
- Conduct training
- Generate and track laboratory notebooks and controlled documents
Qualifications
- A Bachelor’s degree in Chemistry, or science-related discipline with at least five years of demonstrated experience in quality systems operations.
- Experience with the following technologies and test areas: Gas Chromatography, Liquid Chromatography, Mass Spectrometry, Ion Chromatography, ICP-MS (preferred), Analytical Smoking (preferred), Physicals Testing (preferred)
- Knowledge of ISO/IEC 17025, GMP and GLP regulations
- Demonstrated experience with root cause analysis and Corrective and Preventive Action required.
- Experience in the audit process.
- Experience with Track Wise™
- Detailed-oriented with strong analytical and organizational skills.
- Strong written, verbal and presentation skills along with demonstrated ability to collaborate with others.
- Demonstrate strong client service skills, teamwork, and collaboration
- Strong computer, scientific, and organizational skills
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Additional Information
- Position is full-time, Monday- Friday 8 am-5 pm
- May be requested to work on weekends, overtime, and holidays based on business needs.
- Candidates currently living within a commutable distance of Richmond, VA 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
- Authorization to work in the United States indefinitely without restriction or sponsorship
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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