ProCaps Labs
manufacturing
QualitySupervisor
“Quality Supervisor at ProCaps Labs. Skills: Quality Assurance, Quality Control, cGMP regulations, Team leadership. Oversee daily production activities. Monitor manufacturing processes”
Industry & Context.
Analytical skills; Problem-solving skills; Troubleshooting skills
Work extended hours, Work weekends
What They're Looking For.
Must Have
Associate's degree or higher, 5 years of experience in Quality Assurance and/or Quality Control, 2–3 years of supervisory or leadership experience, Working knowledge of FDA cGMP regulations, Experience with laboratory techniques and instrumentation, Proficient in Microsoft Office
Nice to Have
Familiarity with microbiological and/or stability testing
What You'll Do.
Oversee daily production activities
Monitor manufacturing processes
Ensure in-process controls are completed
Ensure process verifications are completed
Generate internal audits
Generate summary reports
Ensure cleanliness requirements are maintained
Ensure sanitation requirements are maintained
Ensure line clearance requirements are maintained
Review batch records for accuracy
Review production documentation for accuracy
Ensure real-time documentation practices are followed
Manage nonconformances
Ensure timely closure of investigations
Perform root cause analysis
Support CAPA processes
Support change control processes
Participate in audits preparation
Participate in audits
Support regulatory inspections
Provide proper responses to inspections
Follow-up on inspection activities
Coordinate with QA/QC leadership
Review quality documentation
Revise quality documentation
Maintain quality documentation
Audit production records
Audit electronic systems
Assist in creation of Master Manufacturing Records
Assist in maintenance of Master Manufacturing Records
Oversee label control processes
Provide support for document control activities
Manage SOP management
Manage record retention
Manage plant-wide environmental monitoring
Supervise laboratory activities
Test in-process materials
Test finished products
Oversee laboratory equipment calibration
Oversee laboratory equipment maintenance
Oversee overall lab operations
Support laboratory investigations
Support OOS/OOT investigations
Support troubleshooting activities
Supervise Quality Technicians
Provide training to team members
Provide coaching to team members
Provide performance feedback to team members
Lead quality meetings
Serve as on-site quality representative
Coordinate with Production
Coordinate with Warehouse
Resolve quality issues
Generate departmental reports
Distribute departmental reports
Generate quality metrics
Distribute quality metrics
Assist in audit follow-up activities
Support facility startup activities
Support continuous improvement initiatives
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Cross-functional activities; Coordinate with Production; Coordinate with Warehouse; Coordinate with QA/QC leadership
Communication Scope
Written communication; Verbal communication
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