Senior Reagent Quality Control Specialist - Molecular

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.
• 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.