Quality Control Analyst II

IRE • Portland, OR

5d • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• Experience with JMP is highly desirable.

Responsibilities

• 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.
• 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.

Benefits

• In addition to your competitive salary, ICON offers a range of additional benefits.
• Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
• Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees