Laboratory Specialist Ii

POSITION DESCRIPTION:
Lab Specialist II

EMPLOYEE: DEPARTMENT: Circumference, LLC
FLSA STATUS: Exempt

REPORTS TO: Lab Specialist Supervisor

SUMMARY: This position will be responsible for managing laboratories. Job responsibilities for this position will be for laboratory processes and procedures and remain in compliance per regulations.

Duties include but are not limited to:

LABORATORY:

● Perform and instruct basic and extensive troubleshooting with LC-MS laboratories (ex. changing pump seals, electrodes, changing vacuuming pump oil, Q0 cleaning, etc)

● Assists Production Associate as needed in solution prep for method validation and other lab solutions
● Contributes to the daily need for analyzing and checking lab results

COMPLIANCE:

● Leads COLA/CLIA laboratory surveys for assigned 360 laboratories including: organizing documentation, interacting with the surveyor and serving as a representative of the laboratory by being onsite during any/all surveys

● Complete COLA/CLIA surveys with a goal of minimal citations depending on involvement level from laboratory staff on-site
● Follows the laboratory’s procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results and proficiency testing
● Ability to identify problems that may adversely affect test performance or reporting of test results. Ability to correct the problems or immediately notify the technical consultant, clinical consultant, or director
● Assists in reviewing and approving Quality Assessments for each laboratory that is overseen, then sends documents to either technical consultant or director for final approval
● Manage bloodborne pathogen testing for lab techs for labs assigned
● Travel to customer sites as needed for pre-audit and audit representation
● Travel to onboard new laboratory setups and implement any SOPs or policies to ensure laboratory is compliant, as needed
● Performs personnel evaluations for any assigned 360 laboratories and ensures that routine tasks are completed in a timely manner (ex. annual lab manual reviews, lab has calibrated pipettes, centrifuge speed is verified, etc)
● Work towards being a moderate complex laboratory director and/or high complexity general supervisor upon approval of management

MANAGEMENT:

● Manage and maintain up to six (6) 360 laboratories
● Managing assigned laboratories and all issues that may need troubleshooting with associated projects
● Manage laboratory technicians at assigned laboratories daily to answer questions, help manage compliance, setup workflows
● Lead assigned 360 laboratory implementation and onboarding process by implementing SOPs, perform method development and method validation, and train the on-site laboratory technician

● Travel to onboard new customers and perform validation and laboratory setup, as needed
● Ensure that assigned laboratory reports are released in accordance to standard turn-around time
● Ensures that each assigned laboratory has enough laboratory supplies to be able to run samples on a daily basis
● Ensures any assigned new laboratories onboarded are able to process samples within 1 week of LS 2 leaving the customer site
● Create initial laboratory report templates for new customers and submits to supervisor for approval
● Contribute to high-priority internal documents to ensure coherency and consistency in data documentation and record keeping
● Manage COLA Central account for all assigned laboratories

SPECIAL PROJECTS:
● Assists supervisor in leading Split Sample Testing Events
● Assist Production Associate in completing Pre-Approvals (as needed)
● Assist supervisor in completing Post-Approvals (as needed)
● Oversee/Monitor assigned LIS clients and maintain working knowledge of LIS product
● Conduct method development once per year to assess methods used and new methods possible (as directed by supervisor and customer needs)

1. Perform laboratory installs

2. Continually manage assigned laboratories and laboratory technicians

3. Serve as laboratory representative during COLA/CLIA surveys

4. Safety standards met

To perform this job successfully an individual must be able to perform each essential duty to a satisfactory standard.
The requirements listed below are representative of the knowledge skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:
● Bachelor’s degree in one of the following disciplines: biology, chemistry, toxicology, clinical chemistry, or relatable life science. (Must have at least 8 credit hours of biology, 8 credit hours of chemistry, and an additional 8 credit hours of either chemistry and/or biology - Transcripts required)

● Previous lab experience of 2+ years including review of analytical data and Quality Control;
● Toxicology experience in a laboratory performing prescription drug monitoring or in a SAMHSA Certified Laboratory

(preferred)

Position Type/Expected Hours of Work:
● This is a full-time position, and days and hours of work are: approx. 40hours/week
● Occasional evening and weekend work may be required as job duties demand.
● Additional hours may be required from time to time.
● Work Remotely - No, on-site only at our Wake Forest, NC location

Travel:
● Can vary from 30-35% depending on workload

Knowledge, Skills, and Abilities:
● Knowledge of basic principles and practical applications of chemistry, biochemistry, toxicology, microbiology, molecular biology, and/or related laboratory specialties.
● Demonstrate the ability to communicate written and verbal scientific and clinical information.
● Good organizational, communication, strong computer database, and laboratory or clinical specimen management skills.
● Ability to perform basic data analysis and peer review to the capacity of at least 75 reports per day.
● Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.

● Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.

● Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one.

● Collaboration - Working effectively and cooperatively with others; establishing and maintaining good working relationships which encourage the free exchange of ideas.

● Science — Using scientific rules and methods to solve problems.
● Quality Control Analysis — Conducting tests and inspections of products, services, or processes to evaluate quality or performance.
● Independence - This role requires someone to be self-motivated and driven in their daily workload.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk or hear.

The employee is occasionally required to sit; climb or balance, and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

This position requires the ability to occasionally lift office products and supplies, up to 20 pounds.

The information presented indicates the general nature and level of work expected of employees in this classification. It is not designed to contain, or to be interpreted as, a comprehensive inventory of all duties, responsibilities, qualifications, and objectives required of employees assigned to this job.

Job Type: Full-time

Pay: $50,000.00 - $53,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Laboratory: 2 years (Required)

Work Location: In person