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Quality Specialist is responsible for supporting and working within the Product Assurance Release team. Responsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems. Ensure that deadlines are met on time and within budget. Limited interface with other departments and business or marketing partners. Work independently with limited supervision and exercise judgment within the defined procedures and practices to determine appropriate actions.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
· Performs batch record review of less complex documentation for finished products such as subassemblies, bulks, labeled reagents and kits.
· Performs approval and final release of less complex documentation for finished products such as subassemblies, bulks, labeled reagents and kits using the EDMS and ERP system.
· Conducts compliance audits of less complex documentation & data.
· Assists in internal and/or walk around audits.
· Serves as QA interface with limited responsibilities.
· Prepares data packages for external customers and regulation bodies.
· Performs compliance activities such as QA Holds, room releases, at-risk processing, etc.
· Assists in new employee training.
· Performs initial troubleshooting activities.
· Assists in maintenance & reporting of department metrics.
· Review and assess the appropriateness of document changes in accordance with internal procedures with oversight and guidance.
Typically requires High school and 4-6 years related experience or AA and 2-4 year related experience or BS and 0-2 years related experience
Basic knowledge of QSR & ISO requirements
Basic computer skills
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Company must have a current executed Company Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Company Recruiter. All resumes must be sent to the Company Recruiter under these terms or they will not be considered.
Company, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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