- Develop, implement, and maintain laboratory quality processes and procedures, in compliance with applicable laboratory regulations
- Maintain compliance with ISO 17025, GMP, GLP and other necessary accreditations.
- Create, revise, review and approve documentation, records, and SOPs.
- Develop mechanisms to identify compliance gaps and facilitate remediation activities where necessary utilizing risk-based prioritization.
- Maintain and update various logs for accuracy and completeness.
- Provide subject matter expertise to drive improvements and decisions relating to quality management systems.
- Work with members of other departments to investigate incidents and nonconformance's.
- Assist with development, implementation, and maintenance of effective departmental QA programs and monitors.
- Assure that QA reviews are effective at identifying and preventing errors, and that corrective actions are followed up for effectiveness.
- Review all laboratory procedures and validation documentation for compliance following regulation and guidance.
- Maintain and update the vendor assurance programs.
- Maintain and organize certificates of analysis.
- Support and participate in internal, client and regulatory agency audits to ensure compliance with certification requirements, laws, regulations, policies, and procedures. Includes routine audit of laboratory departments for compliance with company quality policy and procedure and State requirements where applicable.
- Oversee and manage quality system related meetings, including quarterly management reviews, and collect and trend key performance indicators.
- Keep abreast of new or changing quality and regulatory practices and standards within the industry and coordinate development of or update laboratory compliance standards, guidelines, and programs as appropriate.
- Address quality concerns raised by customers or identified internally, through administration, oversight, and audit programs.
- Carry out duties in compliance with established business policies.
- Demonstrate commitment to the development, implementation, and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Performs other duties and projects as assigned.
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager
1 week ago
Scientific Calibration Inc. Cary, United StatesJob Description · Job DescriptionWe are seeking a Quality Assurance Manager to become an integral part of our team · Job Summary · The Quality Manager is responsible for ensuring that the products and services provided by the company meet both external and internal requirements, ...
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Quality Assurance Manager
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Quality Assurance Manager
3 weeks ago
PCB PIEZOTRONICS, INC. Cary, United StatesThe Primary objective for our Quality Assurance Manager role is to establish and maintain a robust quality system by creating improvements and overseeing the maintenance of our Temposonics Quality system. This would include implementing standards and procedures to control product ...
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager - Cary, United States - Scientific Calibration Inc.
Description
Job Description
Job DescriptionDuties and Responsibilities
