QC Laboratory Analyst II

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 outof-

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:

1. All tasks assigned to LA I:

a. 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.

b. Train to perform basic procedures such as preliminary troubleshooting, repairing and maintaining

analytical instrumentation. Participate in the calibration program for laboratory equipment.

c. 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.

d. Assist with other duties in Quality Control, including complaint investigations and/or pilot product

evaluations.

e. 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.

f. Participate in reviews and updates of SOPs and laboratory methods relating to assigned duties.

g. Participate in the maintenance of laboratory inventory and order supplies as needed.

h. Once a certified trainer, train peers on lab procedures.

1. Perform method optimization and limited method development activities under the guidance of senior

analysts or QC leadership.

1. 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.

1. 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.

1. 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.

1. Assist QC Management with coordination, scheduling and training of laboratory staff on analytical

procedures and processes, including documenting and reporting processes.

1. Utilize training and experience to perform advanced analytical testing and assist with method

development as needed.

1. Assist with sample flow monitoring, throughput metrics, and coordinating and communicating with QC

and other departments to maintain lab turnaround times and goals.

1. 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.

1. Be knowledgeable and informed about company & departmental policies, regulatory requirements and

safety expectations in order to train and assist others in maintaining compliance.

1. Perform all other tasks as assigned by Threshold management