Senior QC Incoming Inspector

Job Title: Senior QC Incoming Inspector

Supervisor: QC Manager

Strategic Focus Areas:

  • Perform all activities within the confines of the Quality System and cGMP principles.
  • Participate in projects and activities which support the growth efforts of the Company
  • Maintain cost discipline within assigned programs

 Specific Tactical Responsibilities:

  • Perform quality line clears and in process inspections during the inspection and packing processes according to specific SOP requirements
  • Issue lot numbers and control labels for incoming raw materials; perform inspections per internal procedures and specifications
  • Release approved raw materials for use in manufacturing process to include completion of associated documents, notice of approval form (bin card) and relabeling of inventory
  • Review MPS of other incoming inspectors for approval and release.
  • Monitor and perform annual retain inspection; coordinate required retesting with QC; complete required documentation
  • Perform OOS investigations and participate in MRB as required for rejected materials
  • Perform as SME for the function and provide training as required to new employees, contractors and other QA personnel
  • Perform biennial review for designated procedures and MPS as needed documents; author and complete DCR as required
  • Document all work activities according to Good Documentation Practice
  • Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required
  • Participate in other projects as assigned

Job Complexity:         

 The position works on assignments that are routine in nature where cGMP experience is required in order to perform work activities.  The Incoming Inspector normally receives little instruction on routine work and detailed instructions and training on new assignments.            

Required Qualifications:

  • Associates degree in the life science or relevant experience
  • Minimum of 5 years of experience in a cGMP facility or previous experience in a QA/QC role within the industry
  • Experience using Microsoft Office or an ERP system

Desired Experience, Knowledge, and Skills:

  • Bachelor’s degree preferred
  • Experience working in a clean room environment
  • Ability to work autonomously, effectively manage time and deliver results on time
  • Excellent communication and documentation skills
  • Previous group lead or supervisory experience preferred
  • Previous experience as a trainer

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