Serve as the main point of contact for external regulatory authorities and internal teams on regulatory matters.
Oversee daily QC testing for physical, chemical, and microbiological parameters for raw materials, packaging materials, in-process samples, and finished products.
Establish, review, and maintain QA documentation, including Standard Operating Procedures (SOPs), Certificate of Analysis (CoA), Batch Production Records (BPR), and product specifications.
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Monitor production quality performance and ensure timely disposition of non-conforming products.\Drive in-process quality control to prevent defects and minimize production disruptions.
Lead investigations into production quality issues and implement effective containment actions.
Conduct and facilitate structured root cause analysis using methodologies such as 8D, 5 Whys, Fishbone Diagram, and FMEA.
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Monitor production quality performance and ensure timely disposition of non-conforming products.\Drive in-process quality control to prevent defects and minimize production disruptions.
Lead investigations into production quality issues and implement effective containment actions.
Conduct and facilitate structured root cause analysis using methodologies such as 8D, 5 Whys, Fishbone Diagram, and FMEA.
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Auditing & Compliance: Conduct internal and supplier audits, ensuring adherence to environmental regulations, chain-of-custody certifications (like PEFC or FSC), and safety codes.
Team Leadership: Train, mentor, and lead QC inspectors, graders, and laboratory staff.
Client & Vendor Liaison: Coordinate with suppliers, third-party inspectors, and clients to resolve quality disputes and ensure product specifications are met.
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Own customer quality communication and complaints through containment, 8D, corrective action, verification and closure.
Lead investigations and cross-functional actions with Production, Engineering, Maintenance, Logistics and suppliers; require containment/rework as needed.
Monitor PPM, rejection, rework, scrap, complaints and Quality KPIs; drive defect prevention and process capability.
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