Intern supporting Software Quality Engineering team at Arthrex. Preparing, executing, and documenting test cases in the office.
About the role
- QA Specialist overseeing quality assurance responsibilities for GMP manufacturing. Collaborating with teams on quality events and regulatory compliance in a biopharmaceutical setting.
Responsibilities
- execution of day-to-day QA responsibilities for GMP manufacturing
- building and enhancing the quality assurance systems
- review and assess all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.)
- provide inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders
- develop, review, and deliver training regarding QMS process or system changes
- support QA QMS in internal and external client audits and regulatory inspections
- monitor and review effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement
- alert senior management of significant quality, compliance, supply, and safety risks
Requirements
- Bachelor’s degree in biological or engineering science
- Minimum of 2 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment
- Ability to collaborate and communicate cross-functionally
- Proven attention to detail.
Benefits
- discretionary annual bonus
- comprehensive benefits to include Medical, Dental and Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- generous paid time off
- paid holiday
- wellness and transportation benefits
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