Position Purpose and Objectives |
The Analytical Chemist job duties consist of the technical aspects of the department in support of directions from the QC Analytical Lab Supervisor and the Quality Operations Manager. He/She is responsible for ensuring regulatory compliance to FDA Guidelines (DSHEA), customer requirements, and departmental function. The primary responsibility is to develop and validate analytical methods for various dietary finished product matrixes and train analysts and chemists. He/She will support analytical testing of incoming raw materials, in-process samples, stability, and finished goods within the QC Laboratory. |
Essential Job Functions |
- Coordinate the testing of raw materials and finished goods with outside labs when required, and allocate results of said testing to the necessary persons.
- Develop and perform analytical methods based on adaptations of USP, AOAC, NSF, or other industrial resources.
- Write SOPs and methods to meet cGMP’s and GLP.
- Validate and qualify laboratory methods including writing of protocols and reports.
- Train chemists and analysts on laboratory methods & procedures when requested.
- Assist and supervise incoming raw materials and finished product analytical analysis.
- Perform daily testing of incoming samples using wet chemical and instrumental techniques, as needed.
- Maintain and record analytical data within prescribed notebooks.
- Compile analytical testing data and issue testing justification documentation.
- Compile lab results and issue completed worksheets for final review.
- Prepare various laboratory reagents as required for daily operations.
- Order and stock all lab supplies required for operation while keeping cost down through effective sourcing and purchasing.
- Ensure accuracy and completeness of all QC logbooks and binders.
- Provide peer review of other chemists’ work as needed.
- Ensure that the QC lab is kept in good repair.
- Communicate issues and non-conformances to the QC Analytical Lab Supervisor and Quality Operations Manager immediately.
- Conduct Lab Investigations for all unexpected results.
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Knowledge, Skills, and Abilities Required |
- Must be Proficient in PC functions, (WORD, EXCEL, ACCESS, POWERPOINT, etc.) and Empower software.
- Must be well organized and detail oriented.
- Demonstrate good verbal and written communication skills.
- Be familiar with and demonstrate excellent advanced laboratory problem solving skills.
- Must be experienced in advanced laboratory testing methods.
- Must be knowledgeable in HPLC configuration including column designs, flow rates, reagent variabilities, wavelengths, and detectors.
- Must be knowledgeable in solubility factors, oil products, water-based products, and oil/water emulsions and the impacts to testing formulations of these designs.
- Must demonstrate Good Laboratory Practice in completing daily work assignments.
- Competent in performing mathematical and scientific calculations as they relate to job function. Communication and management skills.
- Ability to manage, carry out, and prioritize analytical functions.
- Ability to see areas that need improvement and to address them.
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Supervisory Responsibility |
- Responsible for ensuring all requirements for Analytical functions are met.
- Responsible for providing an evaluation of the technical performance of analytical chemists as requested.
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Working Conditions |
- Working functions are generally limited to the QC lab with some facility work at times.
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Minimum Qualifications |
- BS Degree in chemistry, analytical chemistry, instrumental analysis, physical chemistry (or extensive analytical laboratory experience in lieu of degree) .
- 10 years previous laboratory experience.
- Driven, intelligent, and motivated to succeed and improve.
- Extensive Analytical (HPLC) analysis experience
- Excellent people skills, and ability to function under pressure.
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Success Factors |
- Driven and motivated.
- Technical leadership.
- Intelligent and displays aptitude.
- Problem solving skills.
- Detail oriented.
- Self-motivated team player.
- Well organized.
- Willingness to cooperate and work with other departments.
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