Position SummaryThe Senior Reagent QC Specialist- Molecular is responsible for leading, coordinating, and executing the Quality Control (QC) activities for all incoming reagents used in the Molecular laboratory. This role ensures compliance with all relevant regulatory requirements, oversees advanced validation and troubleshooting activities, and serves as a subject-matter resource for internal teams.
The Senior Specialist provides technical leadership in Molecular Reagent QC processes, supports training and onboarding of team members, drives continuous improvement initiatives, participates in investigations, and serves as a key contributor related to Molecular testing and reagent quality processes.
Job Responsibilities- Maintain expert-level compliance with all applicable regulatory standards (CLIA, NYS, CAP, FDA, ISO, etc.).
- Lead the execution and documentation of QC testing for incoming reagents and materials according to established procedures.
- Serve as a subject matter resource for questions related to reagent QC, Molecular workflows, validation activities, and good documentation practices (GDP).
- Perform advanced Molecular Reagent QC testing including, but not limited to, Next Generation Sequencing (NGS), DNA/RNA extraction, nucleic acid quantification, PCR-based testing, DNA methylation analysis, pyrosequencing, and other molecular methodologies as applicable.
- Lead the review and verification of reagent information, including lot numbers, expiration dates, receipt information, specifications, and associated documentation to ensure compliance with established requirements.
- Escalate and communicate discrepancies while partnering with Supply Chain, Receiving, Process Quality, and Laboratory Operations to ensure timely resolution.
- Oversee all reagents pending QC and ensure timely turnaround by monitoring progress, removing barriers, and initiating follow-up actions as needed.
- Lead repeat QC testing as directed by management or the Material Review Board (MRB) and provide QC technical expertise.
- Maintain organization, cleanliness, and compliance of reagent storage units (refrigerators, freezers, RT cabinets) and coordinate disposal or quarantine of nonconforming reagents.
- Support clinical personnel by addressing procedural or technical questions regarding reagent QC processes.
- Lead continuous improvement initiatives focused on streamlining reagent QC workflows, enhancing documentation accuracy, and optimizing efficiency.
- Identify, recommend and implement opportunities to enhance automation, standardization, and error-proofing of reagent QC processes.
- Support the development, implementation, and maintenance of reagent specifications, QC protocols, SOPs, benchsheets, and other controlled documents.
- Serve as a technical mentor and trainer for new and existing Reagent QC staff.
- Contribute to competency assessments, coaching activities, and development of training materials.
- Provide guidance to peers on troubleshooting, best practices, and interpretation of QC results.
- Compile, review, and submit QC documentation for approval by internal quality partners.
- Communicate material issues or trends to cross-functional stakeholders including Supply Chain, Materials Management, Process Quality, and Laboratory Operations.
- Participate in departmental meetings, huddles, process reviews, and improvement discussions.
- Demonstrate strong problem-solving skills, attention to detail, and ability to manage multiple priorities.
- Perform additional duties as assigned by leadership.
Required Qualifications- Bachelor's degree in a scientific field is required (or equivalent work experience).
- 3-4 years' experience working in a regulated laboratory environment (CLIA, NYS, CAP, FDA, ISO, etc.).
- Knowledge of laboratory safety procedures for biohazards and chemicals, as well as quality control procedures and regulations.
- Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook and general working knowledge of Internet for business use.
Preferred Qualifications- Bachelor's or master's degree in a scientific discipline.
- HT/HTL (ASCP) certification preferred; QIHC strongly encouraged.
- 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.
- Familiarity with Root Cause Analysis (RCA) methodologies or formal certification (e.g., 5 Whys, Fishbone/Ishikawa, CAPA, FMEA, or equivalent).
- Knowledge and adherence to good manufacturing and good documentation practices.
Physical Demands- Must possess ability to sit, stand, and/or work at a computer for long periods of time.
- May have exposure to blood-borne pathogens, extreme temperatures, high noise levels, fumes and bio-hazardous material/chemicals including formalin in the lab environment.
- 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.
Training- All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
Other - This position requires periodic travel and some evenings, weekends and/or holidays.
- Job may require after-hours response to emergency issues.
- At times may be required to work weekends/holidays.
Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
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.
