What are the responsibilities and job description for the QA Specialist position at Career Opportunities?
- Serve as the direct contact and QA support for the Probiotics unit:
- Perform contract manufacturing audits; domestic and international.
- Complete batch review, release and issue COA’s
- Lead quality investigations to resolve product quality issues and completed CAPA
- Create routine reports to communicate status, needs and KPI’s
- Create, revise, review and approve Quality Assurance standard operating procedures (SOPs).
- Facilitate/Conduct thorough investigations into quality issues, deviations, complaints, and non-conformances in accordance with ISO9001 and GMP guidelines.
- Utilize problem-solving techniques such as root cause analysis (RCA), failure mode and effects analysis (FMEA), and other quality tools to identify the underlying causes of issues.
- Collaborate closely with cross-functional teams including manufacturing, R&D, regulatory affairs, and quality control to resolve issues promptly.
- Aid peers in developing and implementing effective CAPAs to address identified root causes and prevent recurrence of quality issues.
- Ensure all investigations and CAPAs are documented accurately and in compliance with company policies and regulatory requirements.
- Monitor the effectiveness of implemented CAPAs through follow-up activities and trend analysis.
- Provide support during regulatory inspections and audits related to quality investigations.
- Provide recommendations to improve/reduce frequency of quality events.
- Review Production Batch Records for batch release.
- Support QA inspection and verification functions such as shipping, cleaning and sanitation, etc.
- Provide coaching for QMS software navigation and form entry.
- Maintain trend analysis and create presentations of key quality indicators such as complaints, non-conformance, deviations, action items, OOS
- Perform Raw Material Supplier, Contract Manufacturer, and Contract Laboratory Reviews /Audits
- Support and participate on HACCP/ Food Safety and Food Defense teams.
- Support cleaning and sanitation verification activities
- Must demonstrate the following emotional intelligence skills:
- Emotional Empathy
- Positive Attitude
- Excellent Communication Skills
- Flexibility / Adaptability
- Interpersonal Skills