PositionTitle: Clinical Laboratory Development Reagent and Supplies Specialist

Effective Date: 04/15/2024

Reports To: Molecular Genetics Laboratory Supervisor

Positionstatus: Non-Exempt Full-Time

PrimaryFunction:

The Clinical Laboratory Development Reagent and Supplies Specialist is responsible for reagent preparation, quality control, inventory management, and fulfilling of customer orders for the Reagent Assembly Department. This position interacts directly with customers and must maintain professionalism, courtesy, and timeliness of responses.

Essential Duties and Responsibilities:

• Responsible for the daily monitoring and fulfillment of customer orders, including all associated paperwork and customer and internal correspondence. Fulfilment of orders includes picking, packing, and preparing for shipment, utilizing proper shipment methods, proper shipment conditions, and shipping in compliance with all applicable shipping regulations. Ensures orders are fulfilled correctly and within established timeframes.
• Responds to customer order support requests to provide timely and appropriate responses to positively resolve customer issues.
• Responsible for reagent preparation, including packaging and labeling. Performs reagent verification, analyzes data, evaluates results compared to quality standards, and writes up results for review/approval by technical supervisor.
• Maintains sufficient on-hand inventory to ensure no delays in fulfillment of customer orders. This would include monitoring levels of in-house prepared reagents as well as monitoring levels of all other items needed to fulfill customer orders and ensuring order requests to replenish on-hand inventory are placed well enough in advance to avoid any out of stocks.
• Assists with preparing validation samples and completing reference testing for customer laboratory validations. Includes coordination, receipt, and cataloging of biological samples used to prepare validation samples.
• Maintains stringent standards for quality, identifies any issues which might adversely impact testing quality or employee safety at customer laboratories or internally and communicates these to the appropriate management representatives.
• Maintains general knowledge and understanding of the current products available for customer purchase, to include basic knowledge of the use of the products in a clinical laboratory setting.
• Develops and retains effective partnerships among scientific and administrative partners from diverse sectors of biomedical science (e.g., government, academia, and/or private partners, industry, and not-for-profit organizations).
• Maintains current knowledge of different state regulations for safety, biohazard, and scientific laboratory regulatory and accreditation requirements.
• Participates in ongoing continuing education activities relevant to their position.
• All other reasonable duties, as

Skills, Knowledge, Abilities

Mental Abilities and Skills Requirements

• Proficiency in Windows and Microsoft Office programs, to include Word, Outlook, Teams, and Excel.
• Proficiency in project management software, tools, and techniques, to include Monday.com.
• Ability to multitask and coordinate multiple projects/assignments simultaneously and completing assigned tasks accurately and within needed timelines.
• Ability to adapt in a constantly changing environment and the ability to work under tight deadlines.
• Ability to maintain a high level of accuracy with special attention to detail.
• Ability to document and maintain reagent and ordering records.
• Ability to troubleshoot and solve basic and complex issues.
• Ability to effectively communicate technical information to technical and non-technical audiences; ability to communicate effectively, consistently, clearly, and honestly.
• Ability to take initiative, communicate proactively about anticipated issues, exercise discretion and independent judgment in alignment with company vision and goals, maintain confidentiality, meet deadlines, and work effectively in a team environment.
• Ability to provide excellent customer service and an excellent customer experience.
• Possesses strong analytical, critical-thinking, interpersonal, and team facilitation skills.
• Must be able to process samples without introducing contamination.
• Proficiency in all of the following:
  • BSL2 lab protocols
  • Sterile technique
  • Low volume micro-pipetting (1µl-5µl)
  • DNA extraction (manual and automated)
  • RT-PCR
  • 384-well plating for RT-PCR
  • Data analysis
  • CT/Cq threshold adjustment and analysis
  • Troubleshooting

KnowledgeNeeded

• Knowledge of basic clinical laboratory
• Knowledge of current good manufacturing practices (cGMP).
• Knowledge of order fulfillment processes and best practices.
• Knowledge of shipping regulations for biological and hazardous materials.
• Knowledge of occupational safety and health rules and
• Knowledge of the elements that support high quality work processes and quality assurance in clinical laboratories.
• Knowledge of current CLIA regulations, CAP requirements, and ISO13485 requirements.

Education and Certification

Education/Experience Requirements

• Bachelor’s degree in a life science and at least two years of molecular testing experience. Experience must be sufficient for the candidate to have developed a high level of competency when performing analytical sample processing steps and all other supporting functions.
• Experience manufacturing medical devices in compliance with cGMP and ISO13485.
• Experience operating order management systems and fulfilling product orders.

Other combinations of experience may also be considered as satisfying the requirements for this position.

Certifications

• Supply Chain Warehousing Certificate or equivalent, or willingness to obtain.

PhysicalRequirements:

• Mustbeabletositorstandforupto8hoursper
• Occasionally required to lift up to 20
• Regularlyrequiredtosit,stand,bend,reachandmoveabout

WorkEnvironment:

• Work will be performed mostly in the laboratory spaces. Workweeks usually consist of 40 hours Monday through Friday.

Office Environment -

• Several common areas and meeting rooms for
• Largewindowswhichletinnaturallightduringworking
• Fullyequippedbreakroomand

Lab Environment -

• Noise levels vary based on the flow of
• Most floors are tile or concrete - individuals may stand for extended periods of time on these

Tools and Technology:

• Desktop computer and laptop
• Scanners and printers
• Automated and manual lab equipment

Hazards:

• Workisperformedinalaboratoryenvironment and office environment,fullmanualdexterityandvisualacuity In the laboratory environment, employee may be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools, and equipment.
• HepBVaccinationprovidedatnocostto

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by associates assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Molecular Testing Labs embrace diversity and is an Equal Opportunity Employer, and hire without regard toanyindividual'srace,age,color,nationalorigin,ancestry,disability,veteranstatus,religion,marital status or domestic partnership; pregnancy, childbirth or related medical conditions; other medical conditions or genetic characteristic; sexual orientation, gender, gender identity or transgender status; or any other basis protected by state, federal or local law, regulation or ordinance. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Molecular Testing Labs provides reasonable accommodation upon job seeker request in all steps of the employment process.