Team Lead, Manufacturing - Variable Shift

Role Overview

• Guide and lead the work of department associates executing daily operations
• Act as a point of contact for the production of an assigned run from start to finish
• Assign production support activities to other associates in accordance with the schedule
• Ensure that all production operations are conducted in full compliance with Grifols policies, regulatory (GMP, FDA, ISO) and safety requirements
• Coordinate pre-production checks and activities as required
• Troubleshoot and resolve applicable technical issues encountered in the process
• Coordinate and execute applicable analytical testing activities
• Assist with batch record review and corrections as required
• Review, initiate, and approve change requests for the department
• Initiate production related deviations in the associated quality system
• Manage assigned investigations as required including the implementation of corrective actions.
• Own and manage assigned corrective/preventative (CAPA) actions in the associated quality system
• Coaching and mentoring whenever necessary, foster positive, result-driven teamwork environment.

Requirements

• At least a Bachelor’s in biological or physical sciences
• At least 6 years of experience in the biotechnology/medical device industry
• At least 5 years of experience supporting a GMP environment
• Must have a thorough knowledge of cGMPs including equipment, technology, and quality systems requirements
• Computer skills are required (Word, Excel, Outlook)
• SAP knowledge a plus
• Strong technical knowledge in commercial Immunohematology techniques
• Strong troubleshooting abilities including process monitoring to identify opportunities for continuous improvement
• Must have experience supporting and/or leading deviation investigations.
• Excellent communication skills, organizational skills, writing and problem solving skills required
• Must be able to work independently and make critical decisions
• Must establish proper priorities and manage time and available resources
• Must be able to establish and maintain effective working relationships with customers and co-workers
• Understand the operation of all equipment associated with the process being supervised
• Understand GMP, FDA and ISO regulatory requirements
• 5S, Lean manufacturing knowledge a plus

Benefits

• Medical
• Dental
• Vision
• Life insurance
• PTO
• Paid holidays
• Up to 5% 401(K) match
• Tuition reimbursement