Senior QC Lab Analyst — Method Development & Leadership

Threshold Enterprises; Scotts Valley (CA); In loco; USD 70.000 - 78.000; Tempo pieno

Descrizione del lavoro

Threshold Enterprises in Scotts Valley, CA invites a Laboratory Analyst III to join the QA - Quality Control team. The role involves hands-on analytical chemistry and microbiology, data analysis, documentation, and leadership in a fast-paced lab environment.

You will develop and transfer methods, train junior staff, review test results, and support FDA-cGMP compliance, with opportunities to collaborate across QC, R&D, and planning to help achieve company goals.

Competenze

• Excellent written and verbal communication with strong attention to detail.
• Demonstrated team leadership and training skills.
• Demonstrated process improvement experience.
• Demonstrated professional work skills and attitude.
• 20/20 vision or corrected vision.
• 1+ years of experience in laboratory and chromatography method development/adaptation in an industrial or academic chemistry or biological laboratory or equivalent education and/or experience.
• Degree in Chemistry, Biology, Microbiology or equivalent experience (minimum 3-4 years analytical lab experience and operation of HPLC, LC-MS).

Mansioni

• Perform tasks to LA I and II level; serve as an expert in at least two functional areas.
• Coordinate method development/transfer or adaptation for new and existing laboratory testing techniques (wet chemistry, HPLC, HPTLC, FT-IR, ICP-MS, UV-VIS) per cGMPs; perform lab work, data gathering, and write-ups.
• Provide leadership to LA I and II; lead projects and assist lab management with daily resource/task planning.
• Represent QC in cross-functional meetings (e.g., Material Review Board, Allocation, Supply Review Board).
• Coordinate with lab management and method development team to train LA IIs for transfer of new methods to production lab.
• Review, approve, and release test results, SOPs, and method updates; write reports and lab procedures.
• Assist with database management, data entry/cleanup, metrics tracking, and data analysis reports.
• Collaborate with other QC teams to troubleshoot analyses and processes and investigate OOS.
• Provide troubleshooting for laboratory equipment; participate in instrument research; coordinate IQ/OQ/PQ and calibrations; manage service contracts as needed.
• Support FDA guidelines and cGMP compliance; participate in CAPAs and audits.
• Foster a productive working atmosphere and model professional conduct; contribute to high-performance team goals.
• Perform other tasks as assigned by Threshold management.

Conoscenze

Communication

Leadership

Process improvement

Attention to detail

Analytical chemistry

HPLC/LC-MS experience

Formazione

Bachelor's degree in Chemistry, Biology, Microbiology or equivalent

Strumenti

HPLC

LC-MS

TLC

GC

ICP/MS

FTIR

UV-Vis

Microbiology techniques

Descrizione del lavoro

Threshold Enterprises in Scotts Valley, CA invites a Laboratory Analyst III to join the QA - Quality Control team. The role involves hands-on analytical chemistry and microbiology, data analysis, documentation, and leadership in a fast-paced lab environment.

You will develop and transfer methods, train junior staff, review test results, and support FDA-cGMP compliance, with opportunities to collaborate across QC, R&D, and planning to help achieve company goals.