Team Lead VI
About The Position
The Team Lead VI provides quality oversight across manufacturing areas to ensure product quality and accurate batch records. The role evaluates quality issues with Manufacturing and Quality Assurance, supports manufacturing operations, and helps ensure compliance with GMP, GxP, ISO, data integrity, Good Documentation Practices, and environmental health and safety procedures. The position includes shop-floor walkthroughs, documentation and product inspections, batch-record review and closure, investigation and CAPA support, and oversight of validation activities. The Team Lead also works with Manufacturing and other site departments to resolve issues, support production schedules, and maintain quality metrics and process improvements. The schedule is Saturday and Sunday, 7 a.m.–7 p.m., plus two days during the week. The position may be available in Greenville, South Carolina.
Requirements
- High school diploma required.
- Demonstrated understanding of GMPs and quality system regulations.
- Detail-oriented and well organized, with the ability to multitask and shift priorities to meet operational requirements and customer demand.
- Ability to escalate or solve shop-floor issues according to procedures and use analytical and critical-thinking skills.
Nice To Haves
- Associate degree preferred.
Responsibilities
- Provide quality oversight on the manufacturing shop floor, including daily area walkthroughs and documentation spot checks.
- Serve as a point of contact during off-shift hours for manufacturing issues and determine when issues require immediate escalation or notification.
- Create and revise quality-related documentation and review and approve records within areas of quality oversight.
- Follow procedures and batch records to ensure GMP compliance, data integrity, and Good Documentation Practices, including ALCOA.
- Evaluate quality issues and assist with investigations by providing necessary information and documentation.
- Assist with or perform failure investigations using root-cause analysis tools and propose or implement systemic corrective actions.
- Execute CAPA effectiveness verifications.
- Assist with implementation of process improvements.
- Monitor and conduct in-process inspections, including applicable documentation, visual inspections, testing intervals, and methods as specified by batch records and SOPs.
- Identify suspect material and perform segregation procedures or follow written instructions.
- Check batch documents for correct product, lot number, expiration dates, and components, and conduct online reviews.
- Perform AQL sampling and document 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 batch-document issuance, correction, review, batch-record reviews, and batch-record closure at the end of each line run, including accountability and yield calculations.
- Complete required documentation reviews and work with Manufacturing to resolve outstanding issues before release to Quality Assurance.
- 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 comply 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
Senior
Education Level
High school or GED
