Team Lead VI
About The Position
The Team Lead VI provides quality oversight across manufacturing operations to help assure product quality and accurate batch records. The role evaluates quality issues in collaboration with Manufacturing and Quality Assurance and serves as a point of contact for manufacturing issues during off-shift hours. The position may be based in Greenville, South Carolina. The role monitors manufacturing activities for compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ALCOA data-integrity principles, GxP, ISO, and applicable environmental health and safety procedures. It performs documentation reviews, inspections, investigations, and validation oversight; supports process improvements and corrective actions; and works with Manufacturing and other site departments to resolve issues and support production schedules.
Requirements
- High school diploma required.
- Demonstrated understanding of GMPs and quality system regulations.
- Detail-oriented and well organized.
- Ability to multitask and shift priorities to meet operational requirements and customer demand.
- Ability to escalate or solve shop-floor issues according to procedures.
- Analytical and critical-thinking skills.
Nice To Haves
- Associate degree preferred.
Responsibilities
- Provide quality oversight on the manufacturing shop floor through daily walkthroughs and documentation spot checks.
- Serve as the point of contact for manufacturing issues during off-shift hours and determine when issues must be escalated to site leadership.
- Create and revise quality-related documentation and review and approve records within areas of quality oversight.
- Follow standard operating procedures and batch records to ensure GMP compliance, data integrity, and GDP, including ALCOA practices.
- Evaluate quality issues and assist with investigations; perform or assist with failure investigations using root cause analysis tools, propose and implement systemic corrective actions, and execute CAPA effectiveness verifications.
- Assist with implementation of process improvements.
- Monitor and conduct in-process manufacturing inspections, including required documentation, visual inspections, testing intervals, and methods specified by batch records and current SOPs.
- Identify suspect material and perform segregation procedures or follow provided written instructions.
- Review batch documents for accuracy of product, lot number, expiration dates, and components, and conduct online reviews.
- Perform AQL sampling and document inspection results in batch records.
- Perform product inspections and line-clearance duties according to procedures.
- Interact with Receiving Inspection, Materials Management, Contract Manufacturing, Engineering, Validation, and Quality Control laboratories; assist with and execute protocols and studies.
- Assist Manufacturing with issuing, correcting, and reviewing batch documents, as well as batch-record reviews and closure at the end of each production run, including accountability and yield calculations.
- Complete required documentation reviews and work with Manufacturing to resolve outstanding issues before submitting records to Quality Assurance for release.
- Provide quality oversight of validation activities in assigned areas.
- Support and participate in standardization and quality metrics.
- Support manufacturing schedules and changes.
- Maintain awareness of and compliance with GxP, ISO, and environmental health and safety procedures in the assigned area, and maintain GxP and procedural-reading compliance and personal development.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
