Manufacturing Specialist (MSAT) will implement GMP documentation, manage manufacturing quality events, and partner with internal and external stakeholders to ensure compliance with cGMP and Quality Management systems.
Requirements
- Own, initiate, and manage timely completion of Manufacturing related Quality Events (QEs)
- Coordinate the development, writing, collaboration and review of Standard Operating Procedures (SOPs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation
- Troubleshoot processing issues, investigating in detail and establishing root cause and resolution/corrective action
- Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory and Quality teams
- Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments
- Prepare periodic reports and present data to internal and external stakeholders as needed
- Knowledge management by preparing templates, procedures, and effective training to ensure process are effectively transferred to the operations team
- Work with operations team to create a culture of accountability, ownership, and continuous improvement
- Respect all safety, laboratory policies, and practices on site
- Work across departments and/or sites
- Work with process engineers and manager to align the priorities of the team with those of the department
- Able to work independently; shows initiative and able to work with all levels of staff
Benefits
- Health, vision, and dental insurance
- 401(k) plan
- Bonus or commission