Quality Control Analyst I

ICON Clinical Research; New York (NY); On-site; USD 47,000 - 59,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Life insurance

Job summary

ICON is seeking a Quality Control Analyst I for its Whitesboro, NY site to support the Bioanalytical Laboratory and Project Management Teams. The role conducts QC inspections of samples, notebooks, data and reports, ensuring compliance with protocols and SOPs.

You will help implement the quality management system and maintain thorough documentation across study files. Requires a BS or equivalent with 1+ years lab experience; immunoassay exposure is a plus.

Qualifications

• BS or equivalent combination of experience and education.
• Understanding of client and site needs, and external regulatory requirements.
• 1+ year(s) experience in a laboratory or research environment.
• Immunoassay exposure is a plus.
• Self-starter with learning strategies.
• Self-motivated and able to collaborate with internal groups.

Responsibilities

• Perform quality control (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, SOPs, and applicable regulations.
• Verify operational activities by reviewing notebooks, raw data, and report tables.
• Use rapid feedback to resolve deficiencies found during QC inspection and ensure corrections are made.
• Assist in implementing the quality management system, including corrective and preventive actions.
• Maintain accurate records and ensure QC documentation is included in study files.

Skills

QC inspections

Lab experience

Regulatory understanding

Self-motivation

Education

BS or equivalent combination of experience and education

Job description

Quality Control Analyst I (QC), Bioanalytical, Clinical Research (CRO), Full time, M - F, Whitesboro, New York (NY)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We are seeking a Quality Control Analyst I (QC) to support the Bioanalytical Laboratory and Project Management Teams at ICON's Whitesboro, New York site. The Quality Control Analyst I (QC) will perform quality control (QC) inspections to identify deficiencies and communicate with internal and external teams to resolve deficiencies in a timely manner.

The role:

• Perform quality control (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, raw data, 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.
• Maintain accurate and complete records and ensures QC documentation is incorporated into appropriate study files.

You will need:

• BS or equivalent combination of experience and education and an
• Understanding of client and site needs, and external regulatory requirements
• 1+ year's experience in a laboratory or research environment, highly preferred
• Immunoassay exposure, great to have
• Self-starter with track record of well-developed learning strategies.
• Must be self-motivated and work well with various internal groups.

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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)

Salary range: $46,864.00-$58,580.00

Bonus, Com, Stock, Benefits & Disclaimer verbiage:

Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.