Job Title: Operations Quality Assurance Specialist for Late Stage and Launch Products
Job Summary:
We are seeking an experienced Operations Quality Assurance Specialist to provide operational support for manufacturing operations of our Late Stage and Launch Pipeline products at a new state-of-the-art single-use biotechnology facility. The ideal candidate will have a strong background in quality assurance, technical writing, and compliance.
Key Responsibilities:
- Author Quality Notifications: Draft, review, and finalize quality notifications ensuring clarity, accuracy, and compliance with regulatory requirements.
- Initiate and maintain quality-related metrics related to Quality Notifications ensuring effective communication and follow-up.
- Ensure Quality notifications (including CAPAs, Investigations, and incidents) meet our metrics for raised on time and closed on time while maintaining a high standard of technical writing and compliance.
- Manage the authoring of incident reports documenting quality issues and ensure timely submission for review and approval.
- Lead the authoring of comprehensive investigation reports detailing findings, root cause analyses, and corrective actions.
- Navigate the approval process for all authored documents collaborating with cross-functional teams to ensure timely reviews and compliance with quality management systems.
- Participate in Quality Risk Assessments as needed providing insights and documentation to support the evaluation of quality risks.
- Contribute to a culture of continuous improvement by identifying opportunities for enhancing documentation processes and quality practices.
Requirements:
- Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process Engineering?
- 2+ years of experience in the Biotech Industry (bulk manufacturing of pharmaceutical or biological components)
- Strong technical writing capability and previous experience authoring reports and investigations in a GMP environment
- Competent in analyzing complex situations and showing practical problem-solving capabilities
- Ability to work independently and within a cross-functional team
- Experience in leading and facilitating Root Cause Analysis and Quality Risk Assessment sessions
- Experience supporting Regulatory Inspections and Site Internal Audits
- Understanding of Upstream and Downstream Unit Operations for mAb manufacturing