Katalyst CRO ยท 2 days ago
Quality Assurance Specialist
North Chicago, IL
Contract
Onsite
Senior Level
7+ years expKatalyst CRO is a company focused on research and development in the clinical field. They are seeking a Quality Assurance Specialist responsible for supporting the quality agreement process and driving process improvements while ensuring compliance with regulatory standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Primarily responsible for supporting the Client Research and Development quality agreement process with a focus on identifying and implementing process improvements
Lead or participate in technically complex and strategic cross-functional projects, demonstrating the ability to work across various teams
Drive or support strategic initiatives aimed at improving compliance with regulatory requirements and standards
Take a proactive role in process improvements, which includes the review and update of current supporting processes and procedures to enhance efficiency and effectiveness
Achieve a difficult balance of involvement, independence, and objectivity
Provide support for periodic review of Quality Agreements, ensuring alignment with organizational and regulatory expectations
Collect, analyze, and report relevant metrics to inform decision-making and track the effectiveness of initiatives
Consistently demonstrate Client's Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality
Qualification
Required
Bachelor's degree preferable in a physical science, life science, pharmacy, business, engineering or equivalent experience required
Must have experience with quality agreements and knowledge of worldwide regulatory requirements that influence their content
Persuasive, effective communication skills are essential with an ability to work effectively across functions, across technical areas, and outside of the company
Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills, and sound judgment
Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). BS degree and/or 7 to 7 years equivalent experience
5-7 years of experience in Quality Assurance / Regulatory Affairs (Pharmaceutical or Medical Device preferred)
3-5 years of experience in clinical research and development or manufacturing, or analysis of investigational products
Minimum of 7 years' total combined experience required (Not necessarily the sum of the above)
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
Company data provided by crunchbase