- Responsible for batch record review and disposition of API and Drug Product lots with reference to approved specifications.
- Review, revise and maintain standard operational procedures (SOP) and specifications.
- Review for administration of deviations, out of specification (OOS), and out of trend (OOT) events and participate in preparation of reports.
- Create and administer change control records and follows up on completion of changes.
- Participate in risk assessment and gap assessment as it relates to maintaining compliance with safety, quality and regulatory standards.
- Facilitate employee training on current SOPs according to GxP requirements and archives training records.
- Experienced in MasterControl Quality Management System, especially as a system administrator.
- Experienced in making independent decisions related to controlled document management.
- Responsible for GxP controlled document management and archiving.
- Responsible for attaining and archiving of relevant records from CMOs and Contract labs.
- Perform activities to maintain and improve quality systems.
- Other responsibilities include supporting manufacturing, clinical operations, and supply chain departments as necessary.
REQUIREMENTS
- Knowledge of GMP rules and regulations and ICH guidelines
- Bachelor's or Master's degree in chemistry or one of the life science disciplines
- Minimum 5 years' experience Quality Assurance of Pharmaceutical / biotech industries
- Knowledge and experience with MasterControl as a system administrator with special focus on quality systems, document management, and training modules
- Proficient in Word, Excel, and PowerPoint
- Strong verbal and written communications skills
- A team player
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