Quality Systems Specialist
- East Norriton, PA, USA
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 believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. 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, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.
- Quality interface with e-systems including establishing, implementing, validating and administering policies and procedures
- Provides guidance and education to laboratory personnel on Quality Management procedures and policies and on quality regulations.
- Maintains electronic document control/training/continuing education system for the laboratory. This includes all related status reporting activities
- Writes and revises quality/other procedures and policies, as needed to ensure regulatory compliance
- Audits/works with laboratory staff to ensure Technical Personnel files contain all required documentation is available
- Participates in laboratory licensing activities, as required.
- Participates in external regulatory/accreditation agency inspections, as required
- Able to react to change productively and handle other essential tasks as assigned
- Conducts all activities in a safe and efficient manne
- Demonstrates and promotes the company visio
- Regular attendance and punctualit
- Performs other duties as assigned
- Bachelor’s degree in medical laboratory science or another scientific discipline
- 3 years minimum relevant experience in a laboratory Quality-based role
- Previous experience with electronic document control within a laboratory setting
- Previous experience in the use of different Quality Management software packages (i.e. Pilgrim, Trackwise, Master Control)
- Knowledge of clinical laboratory regulatory standards/requirements and inspection experience
- Previous experience in computer system validation
- Experience with Laboratory Information Management Systems (LIMS) and Asset Management Systems
- Knowledge of data management tools for querying and summarizing data for writing reports. i.e. Access, Excel
- Experience with electronic document control, training/competency, and continuing education software applications a plus
Position is full-time, Monday - Friday 8:00am-5:00pm. Candidates currently living within a commutable distance of East Norriton, PA 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.