Offer summary

Qualifications:

Bachelor’s Degree or equivalent in a related field., At least 5 years of experience in a Quality Assurance role., Fluent in English., Strong knowledge of laboratory quality processes and regulatory compliance..

Key responsibilities:

Develop, review, and maintain SOPs for Quality Assurance.

Conduct audits and participate in vendor and internal quality assessments.

Provide training on quality and regulatory standards to staff.

Manage documentation and support regulatory inspections.

Job description

(Please submit your CV in English)

What You'll Do:

Author, review, and maintain as applicable Standard Operating Procedures (SOP) for Quality Assurance
Provide training and guidance regarding quality and regulatory compliance for laboratory services and junior QA staff.
Manage site electronic document management system including providing system training, document processing, training management, and module management.
Participate and support Risk Assessments within the Quality Management System to continuously improve processes.
Participate in outside qualification audits for vendors supplying services or products, subcontractors, including contract laboratories; resolve and follow-through on any quality issues.
Conduct internal, in-study, and facility-based audits, including equipment/instrument qualifications, equipment calibration and maintenance, software validation and laboratory processes in compliance with SOPs and regulatory requirements.
Conduct reviews of protocols, final reports and contributing scientists’ reports, when
Effectively report quality issues to supervisor, and CTI Laboratory management, as
Provide manage process investigations, nonconforming quality events, client concerns, and the associated CAPA plans.
Host sponsor
Host inspections and help ensure laboratory maintains current licensure and accreditation (as applicable).
Host and/or support regulatory authority
Maintain properly indexed quality assurance Assure all QA records are up-to-date and accurate and compile the appropriate records for archiving.
Attend pre-initiation, pre-planning, or operational team meetings as
Participate in quality projects as
Promote strong relationships within QA, with CTI sponsors, and Department

What You'll Bring:

At least 5 years of related experience in a Quality Assurance role
Bachelor’s Degree or equivalent combination of education and experience
Fluent in English

About CTI

Advance Your Career - We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.
Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process

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