QC Laboratory Analyst III at Threshold Enterprises in Scotts Valley Headquarters - Scotts Valley, CA 95066

Job description

• Summary of Job Duties: The role of the Laboratory Analyst III will include hands-on analytical chemistry & microbiology lab work, data analysis and management, document writing, and leadership. Other important functions are equipment maintenance and troubleshooting, process improvement, and acting as a trainer and role model for other Laboratory Analysts. This position will focus mainly on laboratory functions, but may also work closely with other Quality groups, Research and Development, and Planning to provide expertise, identify and resolve issues, and help achieve company goals.

Responsibilities

• 1. Perform all tasks assigned to LA I and II; serve as an expert in at least two functional areas. Provide cross-functional support where needed.
• 2. 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 cGMP’s. 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
• 3. Provide leadership to LA Is and LA IIs in all aspects of the job. Occasionally lead projects such as monthly lab cleanups, the annual chemical inventory, SOP reviews and updates, and process improvements. Assist lab management with daily resource/ task planning.
• 4. Represent QC in cross-functional meetings (e.g., Material Review Board, Allocation, Supply Review Board) as needed.
• 5. Coordinate with lab management and method development team to provide training to LA Is and IIs for transfer of new methods to the production lab.
• 6. Review, approve, and release test results, SOP and method updates, and new method validation packets. Write reports, memos, SOPs, and laboratory procedures relating to job duties. Perform and document out-of-house method reviews.
• 7. Assist with database management, including some data entry and data clean up, productivity and functionality metrics tracking, and data analysis reports in support of answering questions from QC Management.
• 8. Proactively work with other QC teams, other departments and management to investigate and troubleshoot various analyses or processes to lead to resolution of them in a timely manner, including all aspects of Out of Specification investigations.
• 9. Provide troubleshooting for various laboratory equipment, participate in new instrument research, provide justification and coordination of installation and performance qualifications (IQ/OQ/PQ) of new instruments, coordinating and/or performing equipment calibrations and equipment service contracts as needed and appropriate.
• 10. Assist with company initiative to comply with FDA guidelines and regulations as well as Current Good Manufacturing Practices (cGMPs). Perform and assist with interdepartmental Quality tasks or special projects such as process improvement, CAPAs, and audits.
• 11. 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 set a positive example for new and existing lab team members.
• 12. Participate as a fully engaged member of a high performance, self-directed work team to achieve Department and company goals.
• 13. Perform all other tasks as assigned by Threshold management.

Requirements

• 1. Excellent written / verbal skills and attention to detail.
• 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 3-4 years analytical lab experience and operation of HPLC, LC-MS).
• 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.
• 3 + 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.

Skills

Required

• 20/20 vision or corrected vision

Preferred

• Experience in QC, QA or inspection