Manufacturing Quality Lead; Weekend Shift

Manufacturing Quality Lead (Weekend Shift)

Manufacturing Quality Lead – Weekend Shift
Saturday, Sunday 7 am – 7 pm;
Wednesday, Thursday 2:30 pm – 11 pm

The assurance of quality product and batch records from the manufacturing departments. Evaluates quality issues with Manufacturing and Quality Assurance and provides quality oversight across the site.

• Quality oversight for the manufacturing shop floor.
• Responsible for daily area walk-throughs and documentation spot checks.
• Point of contact during off shift hours for any manufacturing issues.
• Critical thinking and decision making ability is required.
• Determine when to escape issues to site leadership immediately versus providing notification of an event.
• Create and revise quality related documentation.
• Review and approval of records for various areas of quality oversight.
• Follow standard operation procedures and batch records to ensure compliance with Good Manufacturing Practices (GMP) and ensure areas maintain data integrity and proper Good Documentation Practices (GDP), including ALCOA.
• Evaluate quality issues and assist with investigations providing necessary information and documentation when needed.
• Assist/perform failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions.
• Execute CAPA effectiveness verifications to confirm that the corrective actions implemented are effective.
• Assist in implementation of process improvements.
• Monitor and conduct in‑process inspections in the manufacturing area, implementing proper documentation practices, applicable visual inspections, testing intervals and/or methods, as per batch record instructions and current SOP.
• Properly identify suspect material and perform segregation procedures, or per provided written instructions.
• Check batch documents to ensure product, lot number, expiration dates and all components are correct, and conduct online reviews.
• Perform AQL sampling and document inspection results in the batch record.
• Perform product inspections, and line clearance duties per procedures.
• Interact with other departments including Receiving Inspection, Materials Management, Contract Manufacturing, Engineering, Validation, and Quality Control laboratories. Assist and execute protocols and studies.
• Assist the manufacturing team with the issuance, correction and review of batch documents.
• Assist Manufacturing team as needed with batch record reviews and batch record closure on each line at the end of the run including accountability and yield calculations.
• Complete all required documentation review and work with the Manufacturing team to resolve outstanding issues before releasing to Quality Assurance.
• Quality oversight of validation activities for various areas of oversight.
• Support and actively participate in standardization and Quality metrics.
• Support manufacturing schedules and changes.
• Assume responsibility for the GxP, ISO, and environmental health and safety procedure awareness and compliance within the respective area.
• Maintain compliance to GxP and procedural reading; personal development.
• All other duties as assigned.

• Education:
  
  Associate's degree preferred, High School Diploma required.
• Demonstrated understanding of GMPs and quality system regulations.
• Special skills:
  Detail oriented, well organized, and the ability to multi‑task and shift priorities when needed to meet operational requirements and customer demand. Ability to escape/solve shop floor issues per procedures utilizing analytical and critical thinking skills.
• Location:
  
  Greenville, SC.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.