Senior Specialist, Quality Assurance
About The Position
Duties include, but are not limited to the following: Provide Quality review for external production and testing activities for clinical trial material. Review and assess deviations, including risk assessments, participate in root cause analysis investigations, tracking and follow ups. Review and approval of analytical testing protocols, methods and validation report. Work cross functionally to ensure all regulatory requirements are met with regards to the production and testing clinical trial materials as well as the oversight of third parties. Participate in Site Visits and/or Quality audits for CMOs and CTLs as needed. Review of Qualification activities for CMOs and CTLs. Ensure Quality Agreements are followed for contracted activities. Coordinate disposition activities for investigational products by review of executed batch records, deviations, COA and all associated disposition documents for clarity, completeness, compliance with cGMP and conformance to Product Specification. Support review of regulatory filing activities as needed. Establish and maintain internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations. Participate in Health Authority inspections by collecting and presenting documents requested and scribing conversations. Represent Quality at internal and external project team meetings as needed by presenting status updates on QA activities. Communicate with CMOs and Contract Laboratories by defining PepGen requirements and timelines. Experience and Education include, but are not limited to: Bachelor’s Degree in Biomedical Engineering or Pharmacy 36 months of experience Quality Assurance in pharmaceutical/biotech environment
Requirements
- Bachelor’s Degree in Biomedical Engineering or Pharmacy
- 36 months of experience Quality Assurance in pharmaceutical/biotech environment
Responsibilities
- Provide Quality review for external production and testing activities for clinical trial material.
- Review and assess deviations, including risk assessments, participate in root cause analysis investigations, tracking and follow ups.
- Review and approval of analytical testing protocols, methods and validation report.
- Work cross functionally to ensure all regulatory requirements are met with regards to the production and testing clinical trial materials as well as the oversight of third parties.
- Participate in Site Visits and/or Quality audits for CMOs and CTLs as needed.
- Review of Qualification activities for CMOs and CTLs.
- Ensure Quality Agreements are followed for contracted activities.
- Coordinate disposition activities for investigational products by review of executed batch records, deviations, COA and all associated disposition documents for clarity, completeness, compliance with cGMP and conformance to Product Specification.
- Support review of regulatory filing activities as needed.
- Establish and maintain internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations.
- Participate in Health Authority inspections by collecting and presenting documents requested and scribing conversations.
- Represent Quality at internal and external project team meetings as needed by presenting status updates on QA activities.
- Communicate with CMOs and Contract Laboratories by defining PepGen requirements and timelines.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
