QC Reviewer I

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

Position Summary: The Quality Control Technician I, with direct supervision, is responsible for ensuring that data reported to both internal and external customers is accurate and reflects the work performed.

Qualifications

Essential Duties and Responsibilities:

• 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 (BMQ): 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.

 

Education/Experience (BMQ):

• Bachelor’s Degree in a science related field from a four-year college or university; or < 2 years related experience and/or training; or equivalent combination of education and experience.

 

Additional preferences: Watson LIMS experience. Experience with Pharmacokinetic, Immunogenicity, Biomarker, cell based assay execution and data review

Additional Information

• 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

Applicants must be authorized to work for ANY US employer. We are unable to sponsor or take over sponsorship of an employment Visa at this time

Eurofins Viracor BioPharma Services are committed to promoting an equal employment opportunity workplace environment and is an equal opportunity employer. It is the policy of the Company that all qualified applicants will receive consideration for employment  without regard to race, color, religion, sex, age, national origin, citizenship, pregnancy, genetic information (GINA), disability, military and/or veteran status, and/or any other status protected by applicable Federal, state, or local law.  The Company’s policy is to recruit, hire, train, promote and administer all employment-related matters on the basis of an individual's qualifications, abilities and efforts without regard to protected status.

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Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.