Laboratory Technician II - Clinical Pathology and Formulations

Key Accountabilities

• Processes biological specimens for Good Laboratory Practices (GLP) and Non-GLP studies including but not limited to: blood, plasma, serum, synovial fluid, urine, feces, and saliva.
• Completes in-house clinical assays including but not limited to: clinical chemistry, hematology (complete blood count (CBC), reticulocytes, coagulation), and urine sample analysis using automated analyzers.
• Prepares slides and performs microscopic cell counts and differential counts for blood and other biological fluids.
• Creates appropriate study records for collecting, processing, analyzing, and storing samples.
• Prepares labels for biological sample collection and storage tubes according to study protocol requirements .
• Receives chemical test articles and vehicles from study sponsors, logs in and appropriately stores (e.g. room temperature, refrigerator, freezer, etc.). Maintains storage conditions and records for test article reserve.
• Documents use and disposition of test article.
• Coordinates shipments of test articles, samples or other items as needed. Prepares detailed Chain of Custody (COC) for study sample or return test material shipments and files completed COCs when returned from the Sponsor. Complies with Department of Transportation (DOT) Hazardous Materials shipping requirements. Complies with international shipping regulations/documentation when applicable.
• Monitors and records storage conditions (freezer/refrigerator storage units and room temperature storage areas) for GLP and non-GLP test article reserve.
• Maintains inventory and tracks laboratory supplies for expiration dates.
• Apprises management of problems beyond the scope of own knowledge and expertise.

Lab Equipment

• Maintains chemistry, hematology and urine analyzers, and any other necessary clinical pathology instrumentation and equipment.
• Creates and maintains current equipment identification labels.
• Performs appropriate maintenance, calibration and quality control on clinical pathology equipment.
• Maintains calibration testing records on all laboratory equipment including balances, centrifuges, calibration weights, pH meter, hoods, etc.

Formulations

• Prepares control/test article formulations for use in Good Laboratory Practices (GLP) and non-GLP studies. Interacts with Study Director to understand the formulation instructions and assure that the appropriate chemicals/solutions have been received from the sponsor, or that they have been ordered to do the formulation.
• Prepares appropriate study records for formulation of test article and vehicle, as needed. Assures all chemistry data incorporated into study report is complete and accurate.
• Performs monthly inventory of chemicals/drugs and disposal of expired items.
• Receives and maintains Certificate of Analysis (CoA) and Safety Data Sheet (SDS) for chemicals stored in the lab.
• Appropriately stores and disposes of hazardous waste in accordance with local regulations and Environmental Health and Safety (EHS) requirements.

Formulation Development

• Maintains knowledge of modifications and developments in chemical techniques and procedures.
• Researches, develops, and validates new formulation methods.
• Assists in developing and writing formulation procedures for use in GLP and non-GLP studies.
• Suggests and assists in developing refinements to chemical techniques and procedures in use.

Other

• Follows all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures.
• Maintains confidential information.
• Supports and participates in company initiatives as directed.
• Performs periodic review of all applicable SOPs to ensure accuracy and confirm procedures are being performed according to SOPs. Participates in SOP writing, review, and revision, as needed.
• Completes training requirements as assigned and maintains appropriate training documentation.
• Maintains compliance and adheres to all safety regulations, policies, and procedures and good documentation practices.
• Maintains a thorough knowledge and ensures compliance with GLP, United States Department of Agriculture (USDA), Association of Assessment and Accreditation of Laboratory Animal Care (AAALAC), Office of Laboratory Animal Welfare (OLAW), and other applicable regulations.
• Interacts with clients, other employees, and the community in a professional manner.
• Performs other duties as assigned.

Critical Success Factors

• Good organizational skills and detail oriented.
• Excellent communication and interpersonal skills with ability to work with personnel at all levels of the organization.
• Exhibits accuracy and adaptability in performing a wide variety of routine to difficult laboratory procedures requiring advanced knowledge and/or experience and under appropriate regulatory requirements.
• Proficient in the use of a computer to compile and maintain data, spreadsheets, checklists and reports for records and inventory, utilizing the appropriate software.
• Demonstrates an ability to follow detailed instructions with a sense for scientific method.
• Ability to multi-task and participate in multiple projects and department initiatives concurrently.
• Ability to produce high quality results while working under the pressure of strict deadlines.
• Ability to function effectively as a team to achieve department goals.
• Performs procedures and interprets results with minimal direct supervision. If a chemistry problem develops, is able to determine the cause and seek consultation on rectification.
• Knows and understands applicable national and state regulatory agency regulations such as AAALAC and OLAW, with the ability to apply these practices daily, including GLP requirements and their application to clinical pathology operations.
• Ability to document analytical results.
• Ability to read and interpret animal identifications, test results, and instrument reagent specifications.
• Ability to assist in design of experiments, to organize and execute experiments, to maintain accurate records, and summarize results.
• Is familiar with contents of complex reference data and uses published literature and other technical references in completing specific chemistry assignments

Minimum Requirements

• Bachelor's degree in chemistry, related science, or field or Medical Laboratory Technician (MLT) certification
• Three years of direct laboratory experience
• General knowledge of formulation chemistry and instrumentation
• Demonstrated knowledge of concepts and rules of clinical pathologies

Preferred Qualifications

• Working knowledge of a research laboratory
• Knowledge of concepts and rules of animal pathologies

Working Conditions & Physical Requirements
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

(The phrases "occasionally," "regularly," and "frequently" correspond to the following definitions: "occasionally" means up to one-third of working time, "regularly" means between one-third and two-thirds of working time, and "frequently" means two-thirds and more of working time.)

• Ability to regularly lift up to 50 pounds and move heavy equipment in a safe manner
• Ability to stand and move (e.g. walk, bend, reach, lift, crouch, push, pull, lift.) throughout an entire work shift
• Ability to perform, observe, and audit necropsy, surgical, and medical procedures
• Manual dexterity (e.g. feeling, grasping, fingering, repetitive motion) to operate necessary equipment and perform essential tasks outlined in position description
• Required to have close visual acuity (e.g. preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small parts) and depth perception (with or without glasses/contacts)
• Required utilization of provided personal protection equipment (PPE)
• Environmental conditions when working with animals may include working under dirty, dusty or wet conditions
• Occasional exposure to potential hazards such as hot water, steam, mechanical equipment, biological substances, loud noise, odors, chemicals, and to range of outdoor weather conditions
• Regular on-site attendance as scheduled by management
  

#LI-Onsite #LI-OF1

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.