Job Description

** Quality Control Technician I responsibilities include, but are not limited to, the following :**

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

• 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

Qualifications

** 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

Additional Information

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.