Katalyst CRO ยท 4 days ago
CQA Engineer
North Chicago, IL
Contract
Onsite
Senior Level, Lead/Staff
8+ years expKatalyst Healthcares & Life Sciences is a company focused on improving healthcare quality. They are seeking a CQA Engineer to provide expertise in Good Clinical Practice (GCP) requirements and lead strategic initiatives to enhance compliance with regulatory standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Provide an active role within R&D as an expert in GCP requirements. The strategic focus is for early detection and prevention, followed by correction of issues
Collaborate with GCP functional areas and assist in the resolution of external partner quality issues
Lead or participate in technically complex and strategic cross functional GCP projects
Lead or participate in GCP focused strategic initiatives to improve compliance with regulatory requirements and standards
Lead or participate in process improvements, including review / update current supporting processes and procedures
Achieve a difficult balance of involvement, independence, and objectivity
May support Clinical Quality Agreement creation and periodic review
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 preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 8 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries
Thorough understanding of international GCP regulatory standards
Must have a technical background and extensive knowledge of worldwide requirements for quality systems
Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills and sound judgment
Persuasive, effective communication skills are essential with an ability to work effectively across GCP functions, across technical areas and outside of the company
Preferred
Accreditation by a professional body is desirable, e.g., American Society for Quality (ASQ) Certified Quality Manager (CQM), Registered Quality Assurance Professional (RQAP), and/or Certified Quality Auditor (CQA)
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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