What are the responsibilities and job description for the Quality Assurance Manager position at Biorasi?
MANAGER, QUALITY ASSURANCE
SUMMARY OF POSITION:
Collaborates across the organization to ensure adherence to GCP as well as local and industry guidelines and compliance regulations. Conducts site and vendor audits as needed. Prepare and maintain all quality related documentation to include standard operating procedures (SOPs) in support of the QMS. Provide daily oversight of the company’s QMS and notify applicable supervision/management of unauthorized deviations. This includes helping to ensure all employees adhere to all standard operating procedures, as applicable to their individual roles. May conduct regular reviews of quality assurance related metrics and lessons learned and conduct audits to assess procedural compliance.
PRIMARY RESPONSIBILITIES:
· Conduct internal audits for proper adherence to established procedures.
· Conduct external audits as needed.
· Host sponsor and third-party audits of the company.
· Act as a quality assurance liaison with internal and external cross-functional teams, clients, and suppliers.
· Help develop and maintain quality assurance related metrics to help the company understand how it is performing with respect to quality.
· Prepare, revise and control the company’s standard operating procedures (SOPs).
· Investigates and reports on quality assurance related issues to include root cause and corrective action identification and implementation monitoring; partners with the organization to identify and correct any identified issues.
· Perform other duties as assigned
REQUIRED SKILLS AND ATTRIBUTES:
· Strong ability to motivate company personnel to adhere to quality policies and procedures.
· Strong aptitude in the art and science of quality assurance procedures and methods.
· Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.
· Good knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations.
· Ability to conduct root cause analysis and to prepare written remediation plans.
· Keen ability to accurately discern priorities in a resource constrained work environment.
· Demonstrated process improvement skills and aptitude.
· Excellent verbal and written communication skills.
OTHER REQUIREMENTS:
· Bachelor’s degree in applied or life science or business with at least 5 (five) years of related experience in the clinical trial industry, with in-depth knowledge of GCP regulations.
SUMMARY OF POSITION:
Collaborates across the organization to ensure adherence to GCP as well as local and industry guidelines and compliance regulations. Conducts site and vendor audits as needed. Prepare and maintain all quality related documentation to include standard operating procedures (SOPs) in support of the QMS. Provide daily oversight of the company’s QMS and notify applicable supervision/management of unauthorized deviations. This includes helping to ensure all employees adhere to all standard operating procedures, as applicable to their individual roles. May conduct regular reviews of quality assurance related metrics and lessons learned and conduct audits to assess procedural compliance.
PRIMARY RESPONSIBILITIES:
· Conduct internal audits for proper adherence to established procedures.
· Conduct external audits as needed.
· Host sponsor and third-party audits of the company.
· Act as a quality assurance liaison with internal and external cross-functional teams, clients, and suppliers.
· Help develop and maintain quality assurance related metrics to help the company understand how it is performing with respect to quality.
· Prepare, revise and control the company’s standard operating procedures (SOPs).
· Investigates and reports on quality assurance related issues to include root cause and corrective action identification and implementation monitoring; partners with the organization to identify and correct any identified issues.
· Perform other duties as assigned
REQUIRED SKILLS AND ATTRIBUTES:
· Strong ability to motivate company personnel to adhere to quality policies and procedures.
· Strong aptitude in the art and science of quality assurance procedures and methods.
· Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.
· Good knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations.
· Ability to conduct root cause analysis and to prepare written remediation plans.
· Keen ability to accurately discern priorities in a resource constrained work environment.
· Demonstrated process improvement skills and aptitude.
· Excellent verbal and written communication skills.
OTHER REQUIREMENTS:
· Bachelor’s degree in applied or life science or business with at least 5 (five) years of related experience in the clinical trial industry, with in-depth knowledge of GCP regulations.
Quality Control Specialist
Quality Assurance Personnel -
Panama, FL
Quality & Operational Improvement Engineer - Clinical Pathology Quality Assurance
Clinical Pathology Quality Assurance - Jobs@UIOWA Careers -
Iowa, IA
Third Party Quality Inspector
Total Quality Assurance International LLC -
Romulus, MI