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.
The Quality Control (QC) Specialist is responsible for testing and inspecting instrumentation after the manufacturing process to ensure they meet QC criteria. The QC specialist will be required to conduct manual ELISA testing for comparison with results on company instrumentation; keep accurate and detailed records of issues; and monitor inventories to ensure they meet QC standards.
Essential Duties & Responsibilities
1. Acts as Quality representative for changes in Standard Operating Procedures (SOPs)
2. Reviews and approves SOPs ensuring alignment with Regulatory requirements.
3. Leads and assists in investigations of test results
4. Works with production to solve customer/product issues as necessary
5. Maintains all lab equipment and/or calibration of such equipment
6. Maintains cleanliness of lab
7. Monitors product inventories and usage
8. Reviews all Quality Control data to ensure QC criteria are met
9. Establishes and maintains effective working relationships with other departments to ensure communication of problems, issues, and resolutions
10. Performs manual testing following Standard Operating Procedures (SOPs) using Current Good Manufacturing Practices (cGMPs) and Current Good Laboratory Practices (cGLPs)
11. Performs routine testing on manufactured products following Standard Operating Procedures (SOPs) using Current Good Manufacturing Practices (cGMPs) and Current Good Laboratory Practices (cGLPs)
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Undergraduate Degree, Bachelor of Science in biological science or related field. 2-4 years previous work experience in a similar position
Proficient in Microsoft Word, Excel, and Outlook. Must be willing and able to learn other software programs as needed
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several concrete variables.
Knowledge, Skills and Other Abilities
1. General Laboratory knowledge (use of equipment; pipetting; personal safety equipment, general lab practices)
2. Technical knowledge of Immunochemistry
3. Knowledge of FDA Quality System Regulations (cGMP) and International Standards (ISO) pertaining to medical devices
4. Ability to communicate technical information and problems with co-workers
5. Ability to learn new & existing instrumentation and software technology
6. Maintain systems for tracking proper functioning of tests and equipment, software versions, and test file versions
7. May be required to work overtime during heavy manufacturing periods
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