Quality Control Supervisor – Finished Products

MAC Incorporated

Quality Control Supervisor – Finished Products Lake Forest, California
Job Ref:
35733

The Supervisor (Finished Product), Quality Control, is responsible for monitoring and guiding day to day testing activities for finished product in QC laboratory following cGMP. The Supervisor will maintain timely testing of FPs received and timely release of FP to support LF site manufacturing monthly production and financial goals. The Supervisor is responsible for setting up priorities based on the production scheduling and assign each test to the lab staff and communicate on site finance FP meetings weekly for the status of FP release update. Once the tests are assigned the Supervisor will follow through the FP tests and provide bench level supervision for solving any problems encountered during testing. The Supervisor will analyze the monthly work and provide report including identify opportunities for continued enhancement for FP KPI.
 
The Supervisor is responsible to setup development programs for each direct report and provide couching and feedback for individual performance to grow the team member in their career path. The position is a working position that require knowledge and experience in handling FP systems such as annual testing program and rotation marker testing. The supervisor will identify any techniques or innovation project related for RM testing for lab efficiency enhancement. This position will handle different country requirements for FP testing. Previous experience of global regulatory is desirable.
 
The Supervisor will review test results for accuracy and assure the procedure was conducted in adherence with Herbalife SOPs and guidelines. This position will maintain the bench work in compliance with cGMP & ISO 17025 requirements including Herbalife protocols, policies and procedures.
 
DETAILED RESPONSIBILITIES/DUTIES: 
  • Supervise finished product testing supporting LF site manufacturing activities for Monthly production goals.
  • Maintain the FP annual testing program and rotation marker testing program
  • Manage laboratory cGMP compliance and adherence to SOPs and test methods
  • Maintain lab ISO17025 system and accreditation status
  • Provide continued improvements for laboratory systems
  • Provide reports to management pertaining to laboratory activities and project progress
  • Handle OOS investigations for root cause
  • Initiate and implement CAPA
  • Analyze the lab sample and document flows and utilize business intelligence tool for lab efficiency enhancement
  • Liaison with the regulatory authorities on laboratory compliance
  • Facilitate auditing and regulatory inspections to maintain laboratory compliance status
  • Evaluate analysts on laboratory practices and individual performance
  • Provide coaching and feedback for individual for their career growth and develop people in the team.
  • Plan and monitor the execution of lab training and cross-training for lab test backup.
  • Provide troubleshooting guidance and potential solutions for bench testing issues
  • Maintain the instrument qualifications and monitor/schedule the calibration/qualification
  • Provide professional communications for work assignments and follow through the tests and maintain good working environments for keeping lab talents
  • Provide monthly analysis of lab testing on time rate for opportunity of enhancement
  • Guide lab science and technological innovation projects to enhance lab testing efficiency
  • Perform other duties as assigned
 
REQUIRED QUALIFICATIONS:
 
Skills:
  • Ability to work in a fast-paced environment while providing guidance and oversight to the QC laboratory
  • FP testing and troubleshooting experience
  • Proficiency in Microsoft Office (Word, EXCEL, and PowerPoint)
  • Demonstrates problem solving skills and ability to carry out responsibilities
  • Strong customer and results orientation
  • Interacts effectively at all levels with sensitivity to cultural diversity
  • Adaptive, able to evolve with the external environmental and organizational changes
  • Displays an advanced level of knowledge in the field
 
Experience:
  • Laboratory Supervisory experience
  • 5+ years of quality systems experience for cGMP compliance
  • Laboratory Compliance auditing experience for cGMP and ISO17025
 
Education:
  • Bachelor of Science in Chemistry or closely related field
  • GMP Course Training
  • Regulatory training
 
SUPERVISORY RESPONSIBILITIES
  • Supervises a team of Lab Assistants & Chemists 
 
PREFERRED QUALIFICATIONS:
  • Communication and presentation skills
  • Motivational skills
  • Pharmaceutical or Nutraceutical GMP experience
  • Materials testing experience
  • Laboratory testing and trouble-shooting experience
  • Microsoft Office Proficiency Course
  • Methods Development, verification, validation and transfer experience
  • Experience in conducting technical and system training
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