Unither
Quality Assurance Manager
ROCHESTER, NY, US
Sponsorship not specifiedDetected 50 days ago
HRPerformance ManagementPharmacovigilanceLeadershipMentoring
About the role
- Responsible for ensuring Current Good Manufacturing Practices are followed during the Receipt, Sampling, Storage, Testing, Manufacturing, and Distribution of components, intermediates, and finished goods.
- Ensures audits run smoothly and demonstrates controls appropriately.
- Effective, Efficient Quality System (20%) •Provides leadership and management of the Complaint Handling Process.
Responsibilities
- Safe, Effective Products (20%) •Provides management and direction to the Material Release system to ensure products and materials are thoroughly reviewed and meet all regulatory requirements prior to release or rejection. •Manage product recall process. •Leads the team that provides Quality Assurance review and approval of deviations.
- Develops quantitative techniques to monitor process performance. •Evaluates effectiveness of SOP, identifies changes that would enhance the process, and ensures that all change control documentation is implemented. •Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness.
- Develops, plans, and follows through on change initiatives.
- Accepts the ambiguity that comes with changing activities. •Understands HR policies and practices and uses them to manage employees. •Ensuring money, technology, and staff are allocated to achieve optimal results. •Ensures self-esteem and staff keep up to date on technical knowledge and developments that impact roles.
Compensation
- Ensures trends are identified and acted upon if required. •Provides leadership and management of the Annual Product Review (APR) process.
Company info
- Challenges the way it has always been done. •Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance. •Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage. •Ensures stakeholders are appropriately trained on the process and any process changes.
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This listing is sourced directly from Unither's careers page and normalized into a canonical job model.