New York, NY
New York, Remote
ObvioHealth is seeking a Quality Assurance Specialist in the United States with experience in providing support with reviewing and/or writing internal SOPs, participating in external and internal audits, and participating in the incident and CAPA management activities. The Quality Assurance Specialist may be asked to assist in providing training on regulations and other activities at ObvioHealth.
Responsibilities:
Demonstrate knowledge of GCP documentation practices.
Assist in the reviewing and revising of current department SOPs and create new SOPs as required to support ObvioHealth processes.
Perform GCP audits (internal, external and vendor). This includes scheduling, preparing for, conducting, writing the audit report, and approving and follow up of corrective and preventative actions (CAPA).
Support hosting of Client audits and/or Regulatory Inspections.
Develop and conduct training. Support new employee onboarding process.
Maintains effective relationships with colleagues and other departments by working collaboratively to deliver high quality service to the organization.
Perform QC reviews of study documentation, as needed.
Ensures appropriate and timely escalation of quality issues, including issues of significant deviation with projects to QA Management and makes appropriate recommendations for correction and improvement as may be necessary.
Provide support, review, and approval of Quality Incidents and CAPAs.
Support collection, analysis, and reporting of quality metrics.
Performs other tasks and assignments as needed and specified by management.
Requirements:
Bachelor's degree in a scientific discipline and a minimum of 3 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment.
Knowledge and understanding of GCP regulations.
Experience with QA audits.
Ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors.
Proficiency with Microsoft Office.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines preferred.
Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects are preferred.
Experience writing and reviewing SOPs is preferred.
Registered GxP Quality Assurance Certifications preferred.
New York, Remote
ObvioHealth is seeking a Quality Assurance Specialist in the United States with experience in providing support with reviewing and/or writing internal SOPs, participating in external and internal audits, and participating in the incident and CAPA management activities. The Quality Assurance Specialist may be asked to assist in providing training on regulations and other activities at ObvioHealth.
Responsibilities:
Demonstrate knowledge of GCP documentation practices.
Assist in the reviewing and revising of current department SOPs and create new SOPs as required to support ObvioHealth processes.
Perform GCP audits (internal, external and vendor). This includes scheduling, preparing for, conducting, writing the audit report, and approving and follow up of corrective and preventative actions (CAPA).
Support hosting of Client audits and/or Regulatory Inspections.
Develop and conduct training. Support new employee onboarding process.
Maintains effective relationships with colleagues and other departments by working collaboratively to deliver high quality service to the organization.
Perform QC reviews of study documentation, as needed.
Ensures appropriate and timely escalation of quality issues, including issues of significant deviation with projects to QA Management and makes appropriate recommendations for correction and improvement as may be necessary.
Provide support, review, and approval of Quality Incidents and CAPAs.
Support collection, analysis, and reporting of quality metrics.
Performs other tasks and assignments as needed and specified by management.
Requirements:
Bachelor's degree in a scientific discipline and a minimum of 3 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment.
Knowledge and understanding of GCP regulations.
Experience with QA audits.
Ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors.
Proficiency with Microsoft Office.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines preferred.
Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects are preferred.
Experience writing and reviewing SOPs is preferred.
Registered GxP Quality Assurance Certifications preferred.
New York, NY
New York, Remote
ObvioHealth is seeking a Quality Assurance Specialist in the United States with experience in providing support with reviewing and/or writing internal SOPs, participating in external and internal audits, and participating in the incident and CAPA management activities. The Quality Assurance Specialist may be asked to assist in providing training on regulations and other activities at ObvioHealth.
Responsibilities:
Demonstrate knowledge of GCP documentation practices.
Assist in the reviewing and revising of current department SOPs and create new SOPs as required to support ObvioHealth processes.
Perform GCP audits (internal, external and vendor). This includes scheduling, preparing for, conducting, writing the audit report, and approving and follow up of corrective and preventative actions (CAPA).
Support hosting of Client audits and/or Regulatory Inspections.
Develop and conduct training. Support new employee onboarding process.
Maintains effective relationships with colleagues and other departments by working collaboratively to deliver high quality service to the organization.
Perform QC reviews of study documentation, as needed.
Ensures appropriate and timely escalation of quality issues, including issues of significant deviation with projects to QA Management and makes appropriate recommendations for correction and improvement as may be necessary.
Provide support, review, and approval of Quality Incidents and CAPAs.
Support collection, analysis, and reporting of quality metrics.
Performs other tasks and assignments as needed and specified by management.
Requirements:
Bachelor's degree in a scientific discipline and a minimum of 3 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment.
Knowledge and understanding of GCP regulations.
Experience with QA audits.
Ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors.
Proficiency with Microsoft Office.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines preferred.
Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects are preferred.
Experience writing and reviewing SOPs is preferred.
Registered GxP Quality Assurance Certifications preferred.
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