Reagent Quality Control Specialist - Molecular Operations (1st Shift)
Caris Life Sciences
4 hours ago
On-site
Phoenix, AZ
Operations
Position Summary
The Reagent QC Specialist I – Molecular maintains compliance with applicable regulatory requirements for the QC process for all incoming reagents, including initial inspection upon receipt, verification testing/assessment, and review of final QC paperwork prior to Process Quality’s final reagent release into the laboratory.
Job Responsibilities
- Maintain compliance to applicable regulatory requirements (e.g., CLIA, NYS, CAP, FDA, ISO).
- Perform and document Quality Control testing of incoming reagents/materials per applicable procedures.
- Verify reagent information (product name, lot number, expiration date, received date, etc.) against material specification/receipt record, packing slip, reagent packaging, and material management system.
- Alert relevant departments of discrepancies and facilitate corrections.
- Own and maintain reagents pending QC; ensure timely QC testing and follow up on issues delaying QC.
- Perform Molecular Department testing, including (but not limited to) Next Generation Sequencing, DNA Methylation analysis (MGMT), DNA/RNA extractions, and/or DNA/RNA quantification.
- Prioritize QC for urgent reagents requested by Supply Chain, Receiving, or management.
- Direct management and Material Review Board (MRB) on QC repeats; track repeat testing in the reagent tracking system.
- Maintain reagent QC storage units (refrigerators, freezers, room temperature cabinets); dispose of old reagents and follow up on problem reagents.
- Quarantine problem reagents reported by clinical personnel; complete quarantine sign with MRB number when appropriate.
- Answer basic questions about the reagent QC process as needed.
- Compile and submit QC documents for departmental review/approval.
- Maintain laboratory equipment; notify leadership of required maintenance/repairs.
- Identify problems affecting test performance/reporting and take appropriate action.
- Communicate material issues to cross-functional teams as necessary.
- Participate in team meetings/huddles as requested.
- Demonstrate exceptional attention to detail; maintain/completed competency assessments.
- Identify opportunities for improvement; accept other duties as assigned.
Required Qualifications
- Bachelor’s degree in a scientific field (or equivalent work experience).
- 1+ years’ experience in a regulated laboratory environment (CLIA, NYS, CAP, FDA, ISO, etc.).
- Knowledge of laboratory safety procedures for biohazards/chemicals and QC procedures/regulations.
- Proficient in Microsoft Office (Word, Excel, Outlook) and basic Internet use for business.
Preferred Qualifications
- Master’s degree in a scientific discipline.
- ASCP or ASQ certifications.
- NGS and molecular process experience (nucleic acid extraction, PCR, quantification, pyrosequencing).
- Experience executing reagent/material QC.
- Ability to manage multiple tasks and prioritize.
- Experience with electronic document control and QMS systems.
- Knowledge/adherence to good manufacturing and good documentation practices.
Physical Demands
- Ability to sit/stand/work at a computer for long periods.
- Possible exposure to blood-borne pathogens, extreme temperatures, high noise, fumes, and bio-hazardous chemicals/materials (including formalin).
- Ability to lift up to 25 pounds and/or move reagents/materials.
Training
- Completes assigned job-specific safety and compliance training based on job functions.
Other
- 1st shift: 5:00am–4:30pm; periodic travel and some evenings/weekends/holidays may be required.
- Pre-employment: criminal background check, drug screening, credit check (for certain positions), and reference verification.
The Reagent QC Specialist I – Molecular maintains compliance with applicable regulatory requirements for the QC process for all incoming reagents, including initial inspection upon receipt, verification testing/assessment, and review of final QC paperwork prior to Process Quality’s final reagent release into the laboratory.
Job Responsibilities
- Maintain compliance to applicable regulatory requirements (e.g., CLIA, NYS, CAP, FDA, ISO).
- Perform and document Quality Control testing of incoming reagents/materials per applicable procedures.
- Verify reagent information (product name, lot number, expiration date, received date, etc.) against material specification/receipt record, packing slip, reagent packaging, and material management system.
- Alert relevant departments of discrepancies and facilitate corrections.
- Own and maintain reagents pending QC; ensure timely QC testing and follow up on issues delaying QC.
- Perform Molecular Department testing, including (but not limited to) Next Generation Sequencing, DNA Methylation analysis (MGMT), DNA/RNA extractions, and/or DNA/RNA quantification.
- Prioritize QC for urgent reagents requested by Supply Chain, Receiving, or management.
- Direct management and Material Review Board (MRB) on QC repeats; track repeat testing in the reagent tracking system.
- Maintain reagent QC storage units (refrigerators, freezers, room temperature cabinets); dispose of old reagents and follow up on problem reagents.
- Quarantine problem reagents reported by clinical personnel; complete quarantine sign with MRB number when appropriate.
- Answer basic questions about the reagent QC process as needed.
- Compile and submit QC documents for departmental review/approval.
- Maintain laboratory equipment; notify leadership of required maintenance/repairs.
- Identify problems affecting test performance/reporting and take appropriate action.
- Communicate material issues to cross-functional teams as necessary.
- Participate in team meetings/huddles as requested.
- Demonstrate exceptional attention to detail; maintain/completed competency assessments.
- Identify opportunities for improvement; accept other duties as assigned.
Required Qualifications
- Bachelor’s degree in a scientific field (or equivalent work experience).
- 1+ years’ experience in a regulated laboratory environment (CLIA, NYS, CAP, FDA, ISO, etc.).
- Knowledge of laboratory safety procedures for biohazards/chemicals and QC procedures/regulations.
- Proficient in Microsoft Office (Word, Excel, Outlook) and basic Internet use for business.
Preferred Qualifications
- Master’s degree in a scientific discipline.
- ASCP or ASQ certifications.
- NGS and molecular process experience (nucleic acid extraction, PCR, quantification, pyrosequencing).
- Experience executing reagent/material QC.
- Ability to manage multiple tasks and prioritize.
- Experience with electronic document control and QMS systems.
- Knowledge/adherence to good manufacturing and good documentation practices.
Physical Demands
- Ability to sit/stand/work at a computer for long periods.
- Possible exposure to blood-borne pathogens, extreme temperatures, high noise, fumes, and bio-hazardous chemicals/materials (including formalin).
- Ability to lift up to 25 pounds and/or move reagents/materials.
Training
- Completes assigned job-specific safety and compliance training based on job functions.
Other
- 1st shift: 5:00am–4:30pm; periodic travel and some evenings/weekends/holidays may be required.
- Pre-employment: criminal background check, drug screening, credit check (for certain positions), and reference verification.