Moderna is seeking a second shift Quality Assurance Specialist (Monday through Friday, 3pm-11pm) for a position based at their Cambridge, MA site. This position is part of Moderna‚€™s Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in cGMP Manufacturing. The main responsibility for this position is to provide quality oversight of the manufacturing process of drug substance and drug product formulation. The individual will work closely with Drug Product Process Development, Manufacturing, and the Manufacturing Science and Technology team.
This position will also support the successful launch of Phase I products to the clinic in a timely manner. Ensure quality oversight is phase appropriate and scale-able.
Assist in design, qualification, and startup of clinical drug product cGMP manufacturing operations at Moderna‚€™s new facility in Norwood, MA.
Success in this position requires expertise in all aspects of aseptic drug product manufacturing, the ability to work hands on, and the ability to collaborate in a cross-functional, fast paced environment.
- Authors and reviews SOPs and policies. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
- Identifies, classifies and reports deviations, as appropriate and typically works on more complex minor and/or major deviations. Oversees execution of remediation/CPAP activities required to continue production or move a process to the next mile stone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensure timely closure of investigation. Represent
- Responsible for providing quality oversight to the change management system for change controls. This includes providing plan creation oversight, verifying that changes adhere to SOPs and regulatory compliance.
- Review pre-executed batch records and independent technical review of documentation post-execution of cGMP activities. Ensures all specifications are met and that applicable requirements are completed and acceptable.
- Participate in quality oversight of manufacturing, real-time observations of activities
- Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems
- Participate in internal audits for compliance with SOPs, GMPs, and regulations
- Requires a Bachelor‚€™s degree in microbiology, biology, or chemistry
- 5-7 years of quality assurance experience in pharmaceutical industry providing oversight to manufacturing operations
- Demonstrated knowledge of cGMPs in a manufacturing environment
- Strong independent judgement and decision making abilities
- Demonstrated problem detection and problem resolution skills
- Must possess demonstrated organizational skills
- Must possess excellent verbal and written
- Operational Execution
- Decision Making
- Learning Agility
- Impeccable Integrity