Katalyst CRO ยท 3 days ago
Quality Engineering Specialist
Indianapolis, IN
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is a company focused on quality and regulatory compliance in the pharmaceutical sector. They are seeking a Quality Engineering Specialist to lead reliability improvement projects, ensure compliance with regulatory standards, and drive continuous improvement across operations.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead and manage reliability improvement projects within operations and engineering
Author and review Change Control and Quality documents related to product or process modifications
Maintain operational compliance with US and international regulatory standards (FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Review and support validation activities (equipment, cleaning, and process)
Prepare for and participate in regulatory and internal audits
Act as the QA contact for risk management activities, including FMEAs
Investigate deviations, OOS results, and customer complaints, ensuring timely closure with appropriate corrective and preventive actions
Analyze and report batch data to identify trends and compliance risks
Develop, review, and revise SOPs, Batch Records, and training documentation with proper change control
Collaborate cross-functionally to drive problem-solving and continuous improvement across operations
Qualification
Required
Bachelor's degree in Life Sciences or Engineering (required)
2+ years of relevant experience, preferably in a pharmaceutical or aseptic manufacturing environment
Strong understanding of cGMPs and regulatory compliance
Demonstrated expertise in root cause analysis tools (e.g., 5 Whys, Fishbone/6M, TapRoot, Kepner-Tregoe)
Experience with statistical analysis tools; certification in Lean or Six Sigma preferred
Strong project management, organizational, and communication skills
Proficiency with Microsoft Office Suite, MS Project, and Visio
Preferred
Experience with statistical analysis tools; certification in Lean or Six Sigma preferred
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