Katalyst CRO ยท 2 days ago
Quality Assurance Specialist
North Chicago, IL
Full-time
Onsite
Senior Level
7+ years expKatalyst CRO is a company focused on quality assurance in the pharmaceutical sector, and they are seeking a Quality Assurance Specialist to support the Client Research and Development quality agreement process. The role involves leading cross-functional projects, implementing process improvements, and ensuring compliance with regulatory standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices)
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
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
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