Quality Technician - Eurofins PSS Insourcing Solutions, LLC
New Berlin, WI
About the Job
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.
Job DescriptionPosition Summary:
The Quality Technician supports the Quality Assurance Unit (QAU) and Business Unit (BU) in the maintenance of the quality system through document organization, record storage, tracking of quality metrics, as well as other tasks in support of ISO 17025 Accreditation, WDNR Accreditation, DEA Registration, and FDA Registration.
Authority:
The Quality Technician receives sufficient authority from, and is accountable to, the Eurofins SF Analytical Quality Manager, or appointed designate, for the successful completion of assigned duties and responsibilities and has the authority to take action necessary to carry out the duties and responsibilities of this position and to identify the occurrence of departures from the quality system or from the procedures for performing tests and/or calibrations, so long as such action does not deviate from established company guidelines, is consistent with sound technical and business judgment, and follows the practices of the laboratory.
Essential Duties and Responsibilities Include:
- Regular attendance and punctuality.
- Applies GMP/GLP in all areas of responsibility, as appropriate.
- Support compliance of ISO/IEC 17025:2017.
- Provides administrative support in the department and BU as needed (e.g. screening calls, photocopying, scanning, filing of paperwork, etc.)
- Supports department’s various activities (e.g. client visits/audits, scheduling of meetings, agendas, correspondence, documents, shipping, etc), as appropriate.
- Supports digital document management system in the form of drafting/updating SOPs, forms, and other documentation as needed.
- Assist in monitoring for expiring documents and forecasting reviews when needed.
- Supports maintenance of the equipment management system.
- Maintain record storage system for ready access to documents including records retention.
- Support maintaining of the approved vendor list, including subcontract laboratories.
- Update trackers and assign numbers for Non-Conformances, CAPAs and OOSs. Assist with monitoring, reviewing, and updating various trackers.
- Coordinates sampling and testing of deionized water system as per schedule.
- Aid in maintaining training records of staff.
- Conducts all activities in a safe and efficient manner.
- Performs other duties as assigned.
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.
- Requires unquestionable customer service skills, meticulousness, and ability to be persistent while maintaining tact.
- Strong writing and communication skills.
- Strong knowledge of computer software (e.g. Word, Excel, FSA, etc.).
- Demonstrates ability to act independently, exercise discretion and interact with departmental staff and clients.
- Ability to learn new tasks.
- Ability to think critically and solve problems quickly and efficiently.
- Associate degree preferred, or equivalent. With 1+ years of applicable experience.
- At least one year experience in an ISO 17025 or 9001 environment preferred.
- Familiarity with GLP/GMP guidelines for analytical testing preferred.
- Job may require long periods of time working with computer equipment in office environments.
- Overtime and weekend work as required.
- May be exposed to potential food allergens.
Compensation Range:
- $20.00-$25.00 per hour
What we offer:
- 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.