Quality Control Technician I
Eurofins USA Clinical Trial Solutions
Job Description
Job Description
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 Organization 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 Organizations. It also has a rapidly developing presence in highly specialized 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 decentralized 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 2024, 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 Quality Control Technician I responsibilities include, but are not limited to, the following:
ensuring that data reported to both internal and external customers is accurate
and reflects the work performed
- Conducts a QC review of all study generated data as applicable to the different departments throughout the BioPharma Services to assess compliance with internal and external procedures, by the required client timelines
- Inspects assay worksheets for completeness with regards to Test Methods and SOP’s
- Conducts an Equipment and StatLIA printout inspection, ensuring accuracy, completeness and appropriate approvals
- Conducts an inspection of Ancillary documentation
- Provides a determination of acceptance for assays and results
- Performs maintenance of data files and performs various data handling tasks as required
- Understands and follows all procedures and processes required for work performed under the appropriate regulatory body (i.e. GxP, GMP, FDA.GLP and GCP, OECD, CLIA, etc)
- Attends meetings and participates on teams as required
- Reads, understands and maintains compliance on all training documents as required by ETQ
- Checks-in and assists in scheduling projects through the QC department
- Creates where applicable and conducts 10% check of transfer files that are sent to client database
- Investigates discrepant data or client questions or concerns
- Completes other data related tasks as assigned, based on business needs
- Maintains flexibility to meet business needs, for special projects or assisting other team members/departments as needed
- Provides cross-functional support to other departments as required
- Adjusts work hours as needed to meet client deadlines
- Adheres to site employee health and safety (EHS) requirements
- Conducts all activities in a safe and efficient manner
- Demonstrates and promotes the company vision
- Regular attendance and punctuality
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Performs other duties as assigned
Basic Minimum Qualifications:
- Watson LIMS experience preferred
- Experience with Pharmacokinetic, Immunogenicity, Biomarker, cell based assay execution and data review
- Ability to read, write and interpret documents such as safety rules, standard operating procedures, maintenance instructions, and procedure manuals.
- Ability to write read and interpret technical and scientific reports and correspondence.
- Ability to perform mathematical calculations such as averages, dilutions, volumes, molarity and normality.
- Ability to speak effectively before customers and employees.
- Ability to perform statistical analysis and interpretation of data.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited information is available.
- Ability to construct, communicate and interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Authorization to work in the United States indefinitely without restriction or sponsorship
Basic Minimum Education Requirements:
- Bachelor’s Degree in a science-related field from a four-year college or university;
- OR minimum 2 years related experience and/or training with an associates degree in a science related field
Position is full-time working Monday - Friday, 8:00am - 5:00pm . Candidates currently living within a commutable distance of Lenexa, KS 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 USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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