Team Lead, Manufacturing - Variable Shift

Jobtailor; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Grifols in San Diego is seeking a senior production supervisor to guide daily operations, ensuring GMP, FDA and ISO compliance from start to finish of assigned runs.

The role requires strong leadership, problem-solving, and the ability to coordinate pre-production checks, QA investigations, and continuous improvement activities within a regulated biopharma environment.

Qualifications

• Bachelor’s degree in biological or physical sciences required.
• Strong knowledge of cGMPs including equipment, technology, and quality systems.
• Experience in GMP environment.
• Excellent communication and problem-solving skills.

Responsibilities

• 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.
• 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.
• Own and manage assigned corrective/preventative (CAPA) actions in the associated quality system.
• Coaching and mentoring whenever necessary, foster positive, result-driven teamwork environment.

Job description

• 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 resourcesMust 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