Summary of Job Duties: (Onsite Scotts Valley) The role of the Laboratory Analyst III will focus on compliance and include meeting method development productivity goals to meet department and company goals, coordinating with production laboratory supervisor for method transfer and method development efforts involving production staff. Other important functions are data analysis and review, equipment and process troubleshooting, and demonstrating leadership and professional conduct for issue resolution and process improvement - both internally and when representing QC while working interdepartmentally on quality or company projects as needed.

Specific Job Duties:

1. Focus on company initiative to comply with FDA/NSF guidelines and regulations as well as Current Good Manufacturing Practices (cGMPs). Perform and assist with interdepartmental Quality tasks or special projects when necessary including out of house method review, data collections and analysis (ex. CARs and CAPAs) and experimental design and execution

2. Work closely with the QC Manager and Quality Management Team members to set and achieve goals for method development and team process development in order to support business needs. Support and maintain a productive working atmosphere by demonstrating and advocating appropriate professional skills, attitudes and behaviors. Model successful strategies that support proactive forward motion in resolving issues and sets a positive example for new and existing lab team members.

3. Utilizing existing laboratory method resources (USP, Eu Ph, AHPA, AOAC, etc.), perform and coordinate method development / transfer or adaptation for new and existing laboratory testing techniques, including wet chemistry, HPLC, HPTLC, FT-IR, ICP-MS, UV-VIS in accordance with cGMPs. Perform your own lab work, data gathering, research and lab method write up - utilizing production staff only when needed and appropriate by method development testing processes.

4. Coordinate with QC manager and Supervisor to perform the training of production analysts (La1 and LA2) for transfer of methods to the production lab. Also participate in training of staff in general lab skills, safety and general scientific knowledge utilizing your subject matter expertise as needed and appropriate. To include test result review, and document review (all lab levels and management)

5. Write reports, memos, SOPs, and laboratory procedures relating to job duties, including some data entry in company directories, metric tracking and review and specific investigations or project assignments.

6. Proactively work with QC teams, other departments and management to investigate and troubleshoot various analysis or processes to lead resolution of them in a timely manner. Including all aspects of Out of Specification investigations

7. Coordination and or performance of troubleshooting for various laboratory equipment, new instrument research, justification and coordination of installation and performance qualifications (IQ/OQ/PQ), coordinating and or performing equipment calibrations and equipment service contracts as needed and appropriate.

8. Participate as a fully engaged member of a high performance, self-directed work team to achieve Department and company goals. To include daily task/resource planning and general lab maintenance tasks clean-up, chemical inventory management, etc.

9. Perform all other tasks as assigned by Threshold management.

Minimum Qualifications Required:

1. Excellent written / verbal skills and attention to detail.

2. Demonstrated team leadership and training skills

3. Demonstrated process improvement experience

4. Demonstrated professional work skills and attitude

5. 20/20 vision or corrected vision.

6. One years of experience in laboratory and chromatography method development/adaptation (or other analytical instrument method adaptation/development experience) in an industrial or academic chemistry or biological laboratory or an equivalent education and/or experience.

7. Degree in Chemistry, Biology, Microbiology or equivalent experience (minimum 4 years analytical lab experience and operation of HPLC, LC-MS).

Skills and/or Training Desired:

• Experience in QC, QA or inspection, analytical laboratory experience using HPLC, TLC, GC, ICP/MS, FTIR, UV-Vis spectrophotometric, microbiological, and general analytical laboratory techniques.
• 2 years of HPLC, LC-MS, chromatography method development / adaptation.
• Experience in dietary supplement / GMP environment including knowledge and understanding of regulatory guidelines, business needs and practices.