Quality Control Analyst II

ICON plc • Portland, OR

1d • 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. 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. #LI-FL1 What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. 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. 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

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

• 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