Quality Assurance Specialist - Katalyst Healthcares & Life Sciences
Ayer, MA 01432
About the Job
Responsibilities and Requirements:
- Conduct and review investigations of lab deviations and client exceeded concern levels.
- Possess the knowledge and ability to conduct and host client and regulatory audits professionally, ethically, and objectively.
- Assume the role of the CAPA coordinator. Responsible for overseeing the conduct of the CAPA and organizing meetings and updates as necessary.
- Assist the change control coordinator and will assume a role where needed.
- Maintain training records and documentation.
- Conduct review of internal methods and protocols.
- Review documentation such as raw data and reports, quality control records, quality assurance records, and reports for completeness, accuracy, and compliance with methods, protocols, guidelines, and regulations and FDA regulations.
- Assure proper control of laboratory documentation.
- Responsible for the implementation, maintenance, and improvement of quality systems.
- Collaborate with managerial reports and trends.
- Provide guidance to peers regarding quality and regulatory issues.
- Problem-solve quality issues to preserve the original timeline for various projects, tracking progress while accountable for quality system deliverables.
- Accountable for overseeing the lab's adherence to all relevant quality requirements.
- Analyse and identify opportunities to reduce process variation.
- Must have QA process exp from a pharma company.
Source : Katalyst Healthcares & Life Sciences
