Quality Control Technician I

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 SOPs
• 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 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:

• Bachelors 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.

Remote Work :

No

Employment Type :

Full-time