Roles
- Independently applies scientific judgment and contribute to milestones related to specific projects.
- Represents QC business processes and needs within the department and at cross functional forums.
- Maintains cGMP compliance within their laboratories & generates, revises, and/or approves SOP or test methods.
- Ensures that all work is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
- Initiates and owns deviations, CAPAs and change controls within the electronic Quality Management System.
- Supports regulatory inspections and audits
Requirements
- Requires BS degree in Chemistry, Biology or other related scientific discipline.
- Applied knowledge and in-depth understanding of GMP Quality Control systems
- At least 5-7 years’ experience with relevant laboratory experience in a regulated manufacturing or QC laboratory environment.
- It is preferred the candidate have analytical experience with PCR, SDS Page and USP Compendia methods.
- Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
- Completes tasks where judgment is required in resolving problems and recommendations.
- Experience with electronic systems such as LIMS, Trackwise, etc., is an advantage.
