Ecocareers · 3 weeks ago
Quality Engineering Specialist
Indianapolis, IN
Full-time
Onsite
Entry, Mid Level
2+ years expConfidential company is seeking a Quality Engineering Specialist to lead and manage reliability improvement projects within operations and engineering. The role involves ensuring compliance with regulatory standards and collaborating cross-functionally to enhance continuous improvement efforts.
Staffing & Recruiting
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
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase