Laboratory Analyst II

THRESHOLD ENTERPRISES LTD•Scotts Valley, CA

1d•Onsite

About The Position

Laboratory Analysts are responsible for evaluating, inspecting, and testing raw materials, finished goods, and other materials using laboratory analysis equipment and procedures. The Laboratory Analyst II specifically focuses on data review and approval, Out of Specification Investigations, and coordinating with external contract laboratories. This role involves performing skilled analysis for more complex analyses and providing training and guidance to Laboratory Analyst Is. The Laboratory Analyst II is expected to perform most duties of a Laboratory Analyst I, demonstrating a higher level of experience, skill, and ability to work with less supervision.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
Track samples sent out and source 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.