Sr Manager, QC
Position
Summary:
Manage the personnel, material resources, and operations of the Final Quality Control Reagent Microbiology Department.
Responsible for ensuring departmental compliance with all regulations, quality systems, internal and external customer requirements.
Develop, implement, and monitor the performance of Final Quality Control processes, metrics, personnel, and testing methods to ensure reagents conformance.
Provide coaching, feedback, guidance, and training to employees, ensuring an engaged and skilled staff.
Primary Duties:
Develop and maintain quality performance metrics to provide management a method of assessing the effectiveness of production processes, current specifications, test methods, and personnel performance.
Oversee both microbiological and physical inspection testing functions, ensuring efficiency to meet production demands and continuous improvement of departmental performance.
Develop and implement departmental operational procedures to ensure regulatory compliance (FDA, GMP, ISO, CLIA, OSHA, etc.
).
Make recommendations for improving quality & productivity performance, offer troubleshooting expertise, and conduct quality improvement studies where appropriate.
Lead efforts to ensure continuous product and process improvement in areas of responsibility.
Ensure the quality of goods and materials (both physical and biological) to maximize the utilization of resources to meet goals.
Ensure timeliness and efficiency of goods and material testing.
Responsible for developing and maintaining regular Final Quality Control trend data and reports.
Develop and maintain annual departmental budget plans.
Support Reagent manufacturing through management of the environmental monitoring program.
Supports ongoing product stability testing.
Works with other departments to ensure operational and quality goals are understood and met.
Provide methods to communicate the quality status of materials and processes to internal customers, management, and external suppliers.
Support review of customer complaints.
Participate as needed on special teams and/or projects.
Monitor and maintain departmental personnel meet commitments / deadlines.
Lead team members by establishing performance criteria, providing training and resources, giving regular coaching, feedback and guidance.
Ensures an engaged and skilled workforce through active listening and communication.
Position Requirements:
Requires a 4-year degree in scientific or technical field.
Requires a minimum of five (5) years broad quality management experience in a relevant industry (pharmaceutical, medical device, etc.
), with at least three (3) years experience managing people and building quality teams.
Requires advanced knowledge of QC systems, practices, and procedures including microbiological, testing, and inspection processes.
Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.
).
Must have a strong knowledge of GMP, ISO, and FDA compliance.
Recommended Skills Active Listening Biology Business Process Improvement Communication Leadership Metrics Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
Manage the personnel, material resources, and operations of the Final Quality Control Reagent Microbiology Department.
Responsible for ensuring departmental compliance with all regulations, quality systems, internal and external customer requirements.
Develop, implement, and monitor the performance of Final Quality Control processes, metrics, personnel, and testing methods to ensure reagents conformance.
Provide coaching, feedback, guidance, and training to employees, ensuring an engaged and skilled staff.
Primary Duties:
Develop and maintain quality performance metrics to provide management a method of assessing the effectiveness of production processes, current specifications, test methods, and personnel performance.
Oversee both microbiological and physical inspection testing functions, ensuring efficiency to meet production demands and continuous improvement of departmental performance.
Develop and implement departmental operational procedures to ensure regulatory compliance (FDA, GMP, ISO, CLIA, OSHA, etc.
).
Make recommendations for improving quality & productivity performance, offer troubleshooting expertise, and conduct quality improvement studies where appropriate.
Lead efforts to ensure continuous product and process improvement in areas of responsibility.
Ensure the quality of goods and materials (both physical and biological) to maximize the utilization of resources to meet goals.
Ensure timeliness and efficiency of goods and material testing.
Responsible for developing and maintaining regular Final Quality Control trend data and reports.
Develop and maintain annual departmental budget plans.
Support Reagent manufacturing through management of the environmental monitoring program.
Supports ongoing product stability testing.
Works with other departments to ensure operational and quality goals are understood and met.
Provide methods to communicate the quality status of materials and processes to internal customers, management, and external suppliers.
Support review of customer complaints.
Participate as needed on special teams and/or projects.
Monitor and maintain departmental personnel meet commitments / deadlines.
Lead team members by establishing performance criteria, providing training and resources, giving regular coaching, feedback and guidance.
Ensures an engaged and skilled workforce through active listening and communication.
Position Requirements:
Requires a 4-year degree in scientific or technical field.
Requires a minimum of five (5) years broad quality management experience in a relevant industry (pharmaceutical, medical device, etc.
), with at least three (3) years experience managing people and building quality teams.
Requires advanced knowledge of QC systems, practices, and procedures including microbiological, testing, and inspection processes.
Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.
).
Must have a strong knowledge of GMP, ISO, and FDA compliance.
Recommended Skills Active Listening Biology Business Process Improvement Communication Leadership Metrics Estimated Salary: $20 to $28 per hour based on qualifications.
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