About This Role:
We are seeking a highly skilled Quality Specialist to join our team.
This is a dynamic opportunity for an individual who possesses excellent technical writing capabilities, analytical skills, and the ability to work effectively in a fast-paced environment.
The ideal candidate will have experience in quality risk assessments, root cause analysis, and documentation management within a GMP environment.
* Draft, review and finalize quality notifications to ensure clarity, accuracy and compliance with regulatory requirements.
* Initiate and maintain quality related metrics for quality notifications, ensuring effective communication and follow-up.
* Manage the authoring of incident reports, documenting quality issues and ensuring 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 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.
* Ensure authored documents meet necessary compliance standards and are aligned with the manufacturing division quality management systems (QMS).
* Provide guidance to team members on best practices for documentation and compliance, fostering a culture of quality awareness.
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.
* Experience 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.
About Us:
We pride ourselves on our collaborative approach, expert knowledge and exceptional customer service. We are committed to delivering high-quality projects that exceed client expectations.