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Team Lead, Manufacturing - Variable Shift
GrifolsTeam Lead overseeing Immunohematology manufacturing activities at Grifols in San Diego, CA. Leading production teams and ensuring compliance with safety and regulatory requirements.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Medical
- Dental
- Vision
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP KnowledgeBiological SciencesPhysical SciencesTroubleshootingProcess MonitoringAnalytical Testing ActivitiesBatch Record ReviewChange Request ApprovalCorrective ActionsQuality Systems
Soft Skills
Excellent CommunicationOrganizational SkillsProblem SolvingCoachingTeamwork