Job Description

• Scheduling of QC Inspectors for Incoming Components Receiving; Raw Material Receiving Inspection, Manufacturing/Production areas, Warehouse FG auditing, Special Sample handling, Review of Inspection Records, including but not limited to: In-coming Inspection records; In-process Batch Records and related documentation.
• Conduct non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups as related to QC activities.
• Trains and supervises document review personnel; Incoming Inspection records, batch release personnel, issues certificates of conformance (COC), certificates of manufacture (COM), and certificates of analysis (COA) to customers on bulk and work-in-progress (WIP). Maintains accurate record of approved, quarantined, rejected products.
• Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, ISO 13485:2003).
• Maintain working knowledge of OTC Drug requirements for incoming materials and ingredients; components (primary and secondary); intermediates, bulk and FGs.
• Reviews, Approve, Release, Quarantine or Reject per compliance inspection and testing such materials as: Incoming OTC and Cosmetic RMs; Incoming bulk and intermediates; Incoming Components; where applicable, to customer requirements.
• Maintains a working knowledge of QC inspection requirements for components, raw materials, in-process/bulk and finished goods.
• Ensures that review of in-process activities in Manufacturing/Production and Warehouse areas is conducted by QC inspectors for conformance to specifications; follow up on out-of-specifications including non conformances.
• Participates in In-process Quality in-house and outside training program. 
• Conducts periodic analysis of In-process Inspection program for pre-weigh and bulk manufacture and makes recommendations.
• Assist in interpreting and/or developing of customer specifications and requirements for approved formulas.
• Assists in establishing production and assembly inspection information sheets and documentation as required.
• Maintains and updates ERP System, maintains repository of batch records/documents, and other Mfg & Pdn/Assembly in-process Specifications (F/As).
• Reviews of batch records, fill cards, work sheets, and Inspection documentation for completeness and correctness.
• Conduct non-conformance resolutions, complaint investigations, and associated corrective and preventative actions.
• Reviews of QC Inspection reports daily for correctness and completeness. 
• Facilitates on site customer inspections, coordinating availability of product and communication of disposition to Quality and Inventory Control. Interfaces with customer distribution operations where needed.
• Maintains awareness and compliance with safety regulations in performing job duties.
• Ensure that finished goods, bulk, raw materials, components are maintained correctly in the warehouse and other holding areas.
• Assist in the review and release of finished products, when applicable.
• Perform supplier and vendor audits, as well as, Mock recall and internal audits. 
• Ensure compliance to Product Quality Review stipulations.
• Perform the functions of Authorized Person (AP) for goods and materials. 
• Maintain working knowledge of QC Analytical testing including IR, pH, Refractive Index, Viscometer, Spectrophotometry, Vacuum tester, and other Instrumentation.
• Maintain working knowledge of MIL-STD/ANSI/ASQ Sampling and Testing.
• Maintain Standards, Range boards, and Retain Samples Program. 

• Minimum of Bachelor degree (Life Sciences, Engineering, related profession). 
• Five+ years industry or related experience in cosmetic, device, food, or pharma. 
• Previous inspecting, auditing or manufacturing experience - a plus.
• Data analysis, specification development skills.
• Computer literate and effective communication skills.

Benefits: 

• Medical, Dental, and Vision Insurance
• Life Insurance
• 401k match

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