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The Quality Control Manager is a key member of the quality systems team and is responsible for implementing and maintaining the activities of quality control systems and leadership of QC team. Works with technical staff to develop and implement standards, methods and procedures for inspecting, testing and evaluating the compliance of next generation sequencing-related company products and services to established specifications. Evaluates and implements protocols and methods to inspect and test raw materials, in process and finished products. Performs analysis and interpretation of test results, identifies deviations, and makes appropriate recommendations. Oversees product stability testing, preparation of relevant protocols and reports. Revises and updates standard operating procedures as needed. Oversees preparation of protocols for QC methods and equipment qualification/validation studies, execution of studies and report preparation.
The Quality Control Manager is responsible for the day-to-day management of the Quality Control staff and the implementation of quality control procedures and plans, key responsibilities include:
- Establishing and maintaining quality control related policies, procedures and test methods in compliance with global regulatory requirements, including FDA and ISO 13485
- Coordinating QC activities, ensuring quality control in accordance with the requirements of standard operating procedures (SOPs), protocols and product development specification documents
- Participation in development of test methods for existing and new products in collaboration with R&D, Operations and contract manufacturers
- Test method validation activities: prepare validation plans, protocols and reports. Oversee execution of protocols
- Preparation and execution of product stability studies, including protocol and report preparation and ongoing testing
- Review data for compliance to specifications; document and investigate nonconformities
- Lead investigations of laboratory deviations and OOS/OOT results
- Good Documentation Practices of testing and laboratory procedures
- Represent QC on product development teams