Manufacturing Specialist (MSAT) *PC 1602

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