Laboratory Analyst II
: Job Details :

Summary of Job Duties:

Laboratory Analysts are required to evaluate, inspect and test raw materials, finished goods and other materials utilizing the laboratory analysis equipment and procedures. Implement new lab methods. Perform and assist laboratory testing and interdepartmental Quality functions when necessary. Laboratory Analyst I is a trainee or entry level position while Laboratory Analyst II is a journey level class, with leadership tasks, test coordination, training program, statistical metric review and evaluation, and troubleshooting/routine maintenance of lab equipment requirements.

Specific Job Duties Laboratory Analyst I:

Laboratory Analyst I is the entry level and trainee class. Work is of moderate difficulty and is performed in accordance with established policies and procedures, with minimal to moderate supervision.

* Perform various laboratory analyses of a wide range of raw materials, finished products, pilot and vendor samples. Participate in the QC lab's proficiency testing program.

* Become trained to perform basic procedures such as preliminary troubleshooting, repairing and maintaining analytical instrumentation. Participate in the calibration program for laboratory equipment.

* Participate in Out of Specification Investigations (OSIs).

* 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, pilot product evaluations, metric data collection and review, and the compilation of test results - including data entry and result reporting. Contribute to and maintain spreadsheets and databases, and other related duties.

* Write reports, memos, SOPs, and laboratory procedures relating to job duties. Facilitate /coordinate

specific investigations or project assignments.

* Participate in the maintenance of supply needs list and order supplies as needed.

* Data Review.

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

* Perform all tasks assigned by Threshold management.

Specific Job Duties Laboratory Analyst II:

Laboratory Analyst II is the journey level class. 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. Laboratory Analysts II perform the skilled analysis work for more complex analyses and provide training and guidance to Laboratory Analyst Is. Coordinate projects, daily sample flow and assignments, troubleshoot / maintain lab equipment and complete leadership tasks.

* Assist QC Management with coordination, scheduling and training of laboratory staff on analytical procedures and processes, including documenting and reporting processes. Ensure that training metric collection is on track.

* Utilize training and experience to perform advanced analytical testing and assist with method development as needed.

* Review analytical test results and data (both in and out of house data) and become in-house certified to recommend dispositions for materials. Review OSI data, troubleshoot, recommend and/or execute improvements.

* Assist lab management with coordination and execution of special tasks, investigations and projects (inter- and intradepartmental), including cGMP compliance and instrumentation selections and purchases.

* Assist with sample flow supervision, monitoring throughput metrics, coordinating and communicating with QC and other departmental teams to maintain lab turnaround times and goals. Equipment utilization between Production and Methods Development teams.

* Advance department and company goals, including participation in team motivation, morale maintenance, communication of job expectations, promoting achievement of team goals (metrics), and relationship building with all Threshold team members.

* Work with QC Management to evaluate and plan interim use of resources during unplanned staff outages, coordinate coverage plan and communicate to management and staff. Help lead lab teams.

* Guide Lab Analyst I's on work expectations, tasks, policies, goals and reporting requirements.

* Be knowledgeable and informed about company / departmental policies, requirements and regulatory safety requirement in order to train, monitor and enforce staff compliance.

* Attend Production meetings as needed

Qualifications

Minimum Qualifications Required: Laboratory Analyst I:

* 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).

Minimum Qualifications Required: Laboratory Analyst II:

All of the above qualifications listed for Laboratory Analyst I, with the addition of the following:

* At least 1 year (post-graduation) of applied experience in three of the following: HPLC, TLC, FTIR, UV-VIS, or 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 understanding of basic business perspective as it applies to lab operations role

* Demonstrated ability to be constructive and collaborate with management and coworkers with a can-do attitude.

Skills and/or Training Desired Laboratory Analyst I:

* Experience in QC or inspection, analytical laboratory experience using HPLC, TLC, GC, GC-MS, LC-MS, ICP-MS, FTIR, UV-Vis spectrophotometric, microbiological, and /or general analytical laboratory techniques.

* Experience in dietary supplement / GMP environment.

Skills and/or Training Desired Laboratory Analyst II:

All of the above skills and experience listed for a Laboratory Analyst I, with the addition of the following:

* 2-5 years' experience in analytical laboratory in at least three of the following: HPLC, FTIR, UV-Vis spectrophotometric, microbiological, and general analytical laboratory techniques.

* Experience using advanced Excel, reviewing and creating relevant metrics, graphs and reports.