Quality Control Analyst II

Quality Control Analyst II- Portland OR

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

Quality Control Analyst II- Portland OR- On site

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• Perform quality QC) inspections to identify deficiencies   in sample handling/preparation, reagent preparation, laboratory methods, notebooks, raw data, and report tables.
• Review study materials for compliance with the protocol, standard operating procedures (SOPs), and applicable regulations.
• Perform verification of operational activities including review of notebooks, , and report tables.
• Employ rapid feedback loop to resolve deficiencies found during QC inspection.  Ensure subsequent correction(s) are made.
• Assist in the implementation of the quality management system, including  both corrective and
preventive actions.
•  Able to fulfil multiple functional roles, and effectively transition between roles, as business needs dictate.
• Maintain accurate   and complete records and ensures QC documentation is incorporated into appropriate study files.
• Work on continuous improvement initiatives in cooperation with Management.
• Train QC Analysts that are new hires or are cross-training.
• Give direction to QC Verifiers and/or QC Administrator at Supervisor's request.
• To undertake other reasonably related duties as may be assigned from time to time

What you need: 

• Support intermediate and final QC of product by performing testing according to specific product requirements, input data, and summarize results for review by Manager.
• Perform assays to assess stability of products, in-service testing, and support regulatory requirements as requested by strictly following established testing protocol.
• Perform data input, analysis, summarize data, and present findings to Manager.
• Assist with troubleshooting of assays.
• Experience with JMP is highly desirable. 
• Minimum 4 years working in a CLIA/CAP environment
• Bachelor’s degree is required along with 1 year of molecular lab experience.
• Perform molecular diagnostic assays with strict adherence to written test procedures.

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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