QC Laboratory Analyst II

QC Laboratory Analyst II

Scotts Valley Headquarters - Scotts Valley, CA 95066

Overview

Salary Range $28.00 - $28.00 Hourly Position Type Full Time Job Shift Day Education Level 4 Year Degree Travel Percentage None Category QA - Quality Control

Description

Job Purpose Summary:

Laboratory Analysts are required to evaluate, inspect and test raw materials, finished goods and other materials utilizing the laboratory analysis equipment and procedures. The focus of the Laboratory Analyst II is data review & approval, Out of Specification Investigations, and coordinating with out-of-house contract labs. In addition, Laboratory Analysts II perform the skilled analysis work for more complex analyses and provide training and guidance to Laboratory Analyst Is. The Laboratory Analyst II is able to perform all or nearly all duties of Laboratory Analyst I, however, is differentiated by a demonstrated higher level of experience and skill, and ability to work with less supervision.

Key results to be achieved:

• All tasks assigned to LA I:
• Perform various laboratory analyses of a wide range of raw materials, finished products, pilot and vendor samples. Become proficient in one or more of the following testing functional groups: HPLC, Heavy Metals, Microbiology, Botanical ID, and Miscellaneous Chemistry.
• Train to perform basic procedures such as preliminary troubleshooting, repairing and maintaining analytical instrumentation. Participate in the calibration program for laboratory equipment.
• Assist with company initiative to comply with current Good Manufacturing Practices (cGMPs). Participate as a fully engaged member of a high performance, self-directed work team to achieve department and company goals. Participate in interdepartmental QC functions to include process improvements.
• Assist with other duties in Quality Control, including complaint investigations and/or pilot product evaluations.
• Perform metric data collection and data review, and the compilation of test results - including data entry and result reporting. Contribute to and maintain spreadsheets and databases.
• Participate in reviews and updates of SOPs and laboratory methods relating to assigned duties.
• Participate in the maintenance of laboratory inventory and order supplies as needed.
• Once a certified trainer, train peers on lab procedures.
• Perform method optimization and limited method development activities under the guidance of senior analysts or QC leadership.
• Review analytical test results (both in and out of house results) for accuracy and GLPs/GDPs, and recommend dispositions for materials and products based on test results.
• Fill out, review, and approve of Laboratory CoAs for the QC In-Process team, including tracking of statuses and sending completed CoAs to the appropriate groups.
• Manage the Out-of-House Testing program by sending samples daily to the appropriate contract labs, creating purchase requisitions and filling out sample submission forms, using online ordering platforms, and communicating with Accounts Payable to reconcile discrepant purchase orders once testing is completed. Also includes tracking samples sent out and sourcing new methods when requested.
• Assist QC Management with coordination, scheduling and training of laboratory staff on analytical procedures and processes, including documenting and reporting processes.
• Utilize training and experience to perform advanced analytical testing and assist with method development as needed.
• Assist with sample flow monitoring, throughput metrics, and coordinating and communicating with QC and other departments to maintain lab turnaround times and goals.
• Advance department and company goals, including participation in team motivation, morale maintenance, communication of job expectations, promoting achievement of team goals, and relationship building with all Threshold team members.
• Be knowledgeable and informed about company & departmental policies, regulatory requirements and safety expectations in order to train and assist others in maintaining compliance.
• Perform all other tasks as assigned by Threshold management

Qualifications

Minimum Qualifications Required: Laboratory Analyst II:

• Excellent written and verbal skills.
• Strong attention to detail, experience based.
• Ability to lift 30+ pounds.
• 20/20 vision or corrected vision.
• Degree in Chemistry, Biology, Microbiology or equivalent experience (minimum 2 years lab experience – college coursework is applicable).
• At least 1 year (post-graduation) of applied experience in three of the following: HPLC, TLC, FTIR, UVVIS, GC / GC-MS, ICP / ICP-MS or LC-MS instrumental analyses.
• Demonstrated project coordination / project management experience, with confident and resourceful leadership skills.
• Demonstrated experience with process improvement and troubleshooting instrumentation.
• Demonstrated ability to train and mentor others.
• Demonstrated ability to be constructive and collaborate with management and coworkers with a can-do attitude.

Skills and/or Training Desired Laboratory Analyst II:

• Experience in Quality Control or inspection of manufactured products.
• Experience in dietary supplement / GMP environment.
• 2-5 years' experience in an analytical laboratory in at least three of the following HPLC, TLC, GC, GCMS, LC-MS, ICP-MS, FTIR, UV-Vis spectrophotometric, microbiological, and /or general analytical laboratory techniques.
• Advanced experience using Excel, reviewing and creating metrics, graphs and reports.