Position Summary

The Reagent QC Specialist I - IHC is responsible for maintaining compliance to all applicable regulatory requirements pertaining to the QC process for all incoming reagents which includes initial inspection upon receipt, performing applicable validation testing and assessment, and review of final QC paperwork before passing on to Process Quality for final reagent release into the laboratory.

Job Responsibilities

Maintain compliance to all applicable regulatory requirements (CLIA, NYS, CAP, FDA, ISO, etc.).

Ensure that QC Testing of incoming reagents and materials is performed and documented according to applicable procedures.

Reviews / verifies reagent information (product name, lot number, expiration date, received date, etc.) against information / data captured in the material specification or material receipt record, packing slip, reagent packaging, and material management system.

Alerts applicable departments when discrepancies in the parameters listed above are detected and helps to facilitate corrections of errors as needed.

Responsible for owning and maintaining all reagents pending QC and ensuring all QC testing is done in a timely manner. Continuously follows up on any issues delaying QC to ensure all reagents are tested as promptly as possible.

Performs routine histology tasks that pertain to Reagent QC : embedding, cutting, H&E staining and cover slipping as well as high complexity testing such as immunohistochemistry (IHC) staining utilizing automatic staining systems and QC.

Prioritizes QC for reagents needed urgently as requested by Supply Chain, Receiving, or management.

Takes direction from management and the Material Review Board when QC repeats are needed and tracks all repeat testing within the reagent tracking system.

Maintains all reagent QC storage units (refrigerators, freezers, and room temperature cabinets) to ensure they are clean, organized, and any old reagents are properly disposed.

Any problem reagents being held are regularly followed up on until resolution is determined.

Responsible for quarantining any problem reagents found within the laboratory reported by clinical personnel, printing and completing the applicable quarantine sign complete with MRB number when appropriate.

Be available to answer basic questions regarding reagent QC process from clinical personnel or management as needed.

Compile and submit Quality Control documents for review / approval by Departmental partners.

Documents maintenance or testing information as applicable in laboratory logs and the laboratory information system (LIS), as directed by standard operating procedures.

Maintains laboratory equipment and ensures that the equipment is in proper working order and notifies leadership if maintenance and / or repairs are needed.

Demonstrates capability of identifying problems that may adversely affect test performance or reporting of tests results and takes appropriate action.

Communicate material issues to the cross-functional teams, as necessary.

Participate in regular team meetings / huddles as requested by department management.

Demonstrate an exceptional attention to detail.

Identify opportunities for improvement.

Accepts other duties as assigned.

Required Qualifications

1-3 years’ experience in an IHC / histology laboratory required.

Conditions of Employment : Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification.

Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook and general working knowledge of Internet for business use.

Preferred Qualifications

Associate or bachelor’s degree in science field.

HT / HTL (ASCP) certification preferred. QIHC is strongly advised

Graduate from Histotechnology or Medical Lab Technology / Clinical Laboratory Science NAACLS accredited program is preferred.

Ability to manage multiple tasks simultaneously and prioritize as necessary.

Previous Quality Control experience executing reagent or material QC processes.

Previous experience in electronic document control and QMS systems.

Knowledge and adherence to good manufacturing and good documentation practices.

Physical Demands

May have exposure to blood-borne pathogens, extreme temperatures, high noise levels, fumes and bio-hazardous material / chemicals including formalin in the lab environment.

Exposure to formaldehyde, xylene, DAB and alcohol which emit fumes. The formaldehyde, xylene, and DAB are carcinogenic.

May be required to handle blood-borne pathogens and general laboratory reagents.

May be required to lift up to 25 pounds and / or move reagents and materials.

Visual acuity and analytical skill to distinguish fine detail. Ability to pass a visual color discrimination test.

Manual dexterity to use common laboratory equipment and perform sterile techniques as required.

Must possess ability to use a microscope for extended periods of time.

Training

All job specific, safety, and compliance training are assigned based on the job functions associated with this position

Other

This position requires periodic travel and some evenings, weekends and / or holidays.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Last updated : 2024-03-23