Assistant Manager, Chemical Testing

Overview

POSITION SUMMARY STATEMENT:

The supervisor QC, will be responsible for monitoring and guiding day to day chemical testing activities for Raw materials, finished products and R&D samples in QC laboratory following cGMP. The supervisor will support manager in maintaining timely testing and release of all received samples to support India R&D and manufacturing goals.The position is a working position that require knowledge and experience in handling food /nutraceutical/ botanical sample testing. The supervisor will identify any techniques or innovation project related to food/ nutraceutical/ botanical testing for lab efficiency enhancement. 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 and ISO 17025 requirement including Herbalife protocols, policies and procedures.

DETAILED RESPONSIBILITIES/DUTIES:

• Supervise testing of food/nutraceutical/botanical sample from R&D, manufacturing and stability as per schedule.
• Maintain annual testing program for food/nutraceutical/botanical samples and rotation marker testing program
• Supervise laboratory cGMP compliance and adherence to SOPs and test methods
• Maintain ISO17025 compliance and accreditation status
• Performs laboratory testing (qualitative and quantitative chemical and physical analysis of raw materials, finished products and/or stability samples). Reviews laboratory testing results under minimal supervision.
• Prepares standards and reagents; calibrates and operates sophisticated laboratory instrumentation such as LCMSMS, ICPMS, ICPOES, HPLC, UPLC, FTIR, UV- Visible spectrophotometer.
• Reviews product certificates of analysis for accuracy and conformance and maintain C of A files.
• Review and track Calibration and Preventive Maintenance (PM) schedule. Performs routine calibration and performance verification of lab equipment and instrumentation.
• Independently perform investigations, address Out of Specifications (OOS), resolve deviations and implement CAPA with minimal supervision.
• Troubleshoots lab equipment or instrumentation and methods.
• Identify improvement opportunity and provide training to junior level staff.
• 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 test backup
• Provide trouble shooting 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 technology 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
• Testing of food/nutraceutical/botanical sample and their analytical troubleshooting experience
• Proficiency in Microsoft office (Word, Excel, Power Point)
• Demonstrates problem solving skills and ability to carry out responsibilities
• Good organizational skills.
• Demonstrate good verbal and written communication skills.
• Ability to draft validation protocols and reports.
• Interacts effectively at all levels with sensitivity to cultural diversity
• Adaptive, able to evolve with the external environment and organizational changes
• Display and advanced level of knowledge in analytical chemistry

• Ability to function as an effective team member

Experience:

• 8-10 Years of industrial experience in nutrient analysis for food/nutritional/herbal/botanical products, minimal 1 year on supervisor role
• Audit experience for cGMP and ISO 17025 quality systems
• Food/Nutraceutical laboratory work experience

Education:

• Bachelor of Science in Chemistry or closely related field
• GMP course training
• Regulatory training

SUPERVISORY RESPONSIBILITIES:

• May, supervises a team of Lab assistants and chemists

PREFERRED QUALIFICATIONS:

• Communication and presentation skills
• Motivational skills
• Strong customer and result orientation
• Pharmaceutical or Nutraceutical GMP experience
• Laboratory testing and trouble-shooting experience
• Method development, verification, validation and transfer experience
• Experience in conducting technical and system training