Overview
POSITION SUMMARY STATEMENT:
The level II Chemist should have a solid skill in applying chemistry knowledge to project assignments in theexperimental design and planning stage. This role will perform standard chemical and physical analysis of inner and outer nutritional products in the quality control lab using wet chemistry techniques and instrumental analyses.
DETAILED RESPONSIBILITIES/DUTIES:
- Performs laboratory testing (qualitative and quantitative chemical and physical analysis of raw materials, finished products and/or stability samples). Reviews laboratory testing results under general supervision.
- Interprets test results and compares with determined standards and limits. Interprets and compares data and historical records and trend verification under general supervision.
- Writes chemical analysis procedures for incorporation into test methods.
- Assists junior chemists to run experiments for release and stability studies.
- Provide training to junior level staff.
- Maintains a safe, clean and efficient laboratory.
- Prepares standards and reagents; calibrates and operates sophisticated laboratory instrumentation such as HPLC, 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.
- Demonstrate solid knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP). Documents data in lab notebook and follow basic cGMP guidelines. Take active roles to ensure that laboratory is in compliance.
- Assist in audit and compliance program as needed.
REQUIRED QUALIFICATIONS:
Skills:
- Ability to execute testing according to established methods and provide recommendations for improvement of test methods
- Demonstrates proficiency in lab instrumentation and multiple test methods
- Ability to solve practical problems and carry out responsibilities under minimal supervision
- Ability to organize workload for effective implementation
- Strong customer and results orientation
- Ability to interact effectively at all levels with sensitivity to cultural diversity
- Ability to function as an effective team member/leader with specialized areas of laboratory expertise
- Ability to adapt as the external environment and organization evolves
Experience:
- 5-7 years’ experience in an analytical laboratory of qualitative or quantitative analyses
- Experience in various wet chemical analysis and/or instrumental analysis utilizing FTIR, HPLC, GC and UV-Visible spectrophotometry
- Superb knowledge of cGMP guidelines
- Experience in ISO 17025 accredited food testing lab
- FSSA(I) certified Food Analyst (Preferred)
- Nutraceutical or pharmaceutical laboratory work experience
Education:
- Bachelor of Science in Chemistry, Biochemistry or related scientific fields
PREFERRED QUALIFICATIONS:
- Solid knowledge in LC/MS and GC/MS
- Previous cGMP regulation and compliance knowledge
- Nutraceutical or pharmaceutical laboratory work experience
- Solid knowledge in ISO17025 Lab Management
- Master of Science in Chemistry, Biochemistry or related scientific fields
