Quality Control Specialist I
Geneoscopy, Saint Louis, MO, United States
Quality Control (QC) Specialist I
We are looking for a Quality Control (QC) Specialist to perform quality control activities related to medical records and other quality documentation throughout the testing and manufacturing lifecycle. This on‑site, in‑office position at Geneoscopy HQ in St. Louis, Missouri ensures accuracy, completeness, and compliance with internal procedures, regulatory requirements, and quality standards. The specialist reviews and verifies records, identifies discrepancies, and supports timely resolution to maintain data integrity and product quality. The role collaborates cross‑functionally with laboratory, manufacturing, and quality teams to support efficient operations and continuous improvement within the quality management system.
Responsibilities
Conduct QC reviews of sample/specimen data for accuracy throughout the testing process.
Assure the quality of products by evaluating incoming materials, inspecting components and products at various stages, and evaluating the functionality of finished products using ddPCR.
Support laboratory and clinical operations, performing QC checks on data and manual entries as needed.
Collaborate with laboratory personnel to open nonconformances for inaccurate data.
Track and trend QC data and prepare quality presentations.
Assist in maintaining compliance with all applicable regulations and requirements (CLIA, CAP, NYS, DOH, FDA, ISO, etc.).
Support the Quality Management System, including nonconformances and customer complaint processes.
Conduct gap analyses and best practice reviews to sustain and continually improve the Quality Management System.
Participate in internal and external audits and manufacturing inspections.
Review incoming material release inspections.
Navigate and execute laboratory equipment inspections.
Review, revise, author, and implement new procedures and controls to achieve regulatory compliance and operational efficiency.
Perform work under general supervision, navigating through moderately complex problems.
Demonstrate solid knowledge of the subject matter.
Other duties as assigned.
Education Requirements
Bachelor's Degree in a science-related field is required.
Preferred: a degree in Biology or Chemistry.
Qualifications
1–2 years of experience in a CLIA/CAP or QSR-regulated environment.
Minimum of 2 years of PCR testing experience.
Ability to read and understand technical procedures and instructions.
Multitasking skills in an agile, fast‑paced, deadline‑driven environment while remaining flexible, proactive, resourceful, and efficient.
Proficient verbal and written communication skills, willing to share and receive information and ideas at all levels of the organization.
High ethics and professional conduct.
Inclusive and collaborative mindset, stepping up to responsibility and making tough decisions while being accountable.
Results‑oriented team player with strong interpersonal skills, capable of working collaboratively with colleagues.
SCHEDULE
This is a salaried position, requiring at least 40 hours per week. Projects may require work beyond the standard hours.
Compensation & Benefits
Base salary range: annual amount determined based on experience, knowledge, and abilities.
Discretionary annual bonus based on a percentage of the employee's base salary.
Benefits include health, vision, dental, life insurance, 401(k) with employer match, and paid time off.
Company stock options.
Geneoscopy's Core Values
Integrity - we do the right thing through our words, actions, and behaviors.
Courage - step up, speak up, stand out.
Agility - think and act fast, embracing change.
Passion - for our customers, our people, our work, and for excellence.
Collaboration - our differences are assets.
Physical Demands
Employees may be required to lift routine office supplies and use standard office equipment.
Must be able to sit and/or stand for long periods.
Must be able to perform repetitive motion.
Work Environment
May have exposure to fumes and bio‑hazardous material in the laboratory environment.
May be required to handle blood‑borne pathogens and general laboratory reagents.
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We are looking for a Quality Control (QC) Specialist to perform quality control activities related to medical records and other quality documentation throughout the testing and manufacturing lifecycle. This on‑site, in‑office position at Geneoscopy HQ in St. Louis, Missouri ensures accuracy, completeness, and compliance with internal procedures, regulatory requirements, and quality standards. The specialist reviews and verifies records, identifies discrepancies, and supports timely resolution to maintain data integrity and product quality. The role collaborates cross‑functionally with laboratory, manufacturing, and quality teams to support efficient operations and continuous improvement within the quality management system.
Responsibilities
Conduct QC reviews of sample/specimen data for accuracy throughout the testing process.
Assure the quality of products by evaluating incoming materials, inspecting components and products at various stages, and evaluating the functionality of finished products using ddPCR.
Support laboratory and clinical operations, performing QC checks on data and manual entries as needed.
Collaborate with laboratory personnel to open nonconformances for inaccurate data.
Track and trend QC data and prepare quality presentations.
Assist in maintaining compliance with all applicable regulations and requirements (CLIA, CAP, NYS, DOH, FDA, ISO, etc.).
Support the Quality Management System, including nonconformances and customer complaint processes.
Conduct gap analyses and best practice reviews to sustain and continually improve the Quality Management System.
Participate in internal and external audits and manufacturing inspections.
Review incoming material release inspections.
Navigate and execute laboratory equipment inspections.
Review, revise, author, and implement new procedures and controls to achieve regulatory compliance and operational efficiency.
Perform work under general supervision, navigating through moderately complex problems.
Demonstrate solid knowledge of the subject matter.
Other duties as assigned.
Education Requirements
Bachelor's Degree in a science-related field is required.
Preferred: a degree in Biology or Chemistry.
Qualifications
1–2 years of experience in a CLIA/CAP or QSR-regulated environment.
Minimum of 2 years of PCR testing experience.
Ability to read and understand technical procedures and instructions.
Multitasking skills in an agile, fast‑paced, deadline‑driven environment while remaining flexible, proactive, resourceful, and efficient.
Proficient verbal and written communication skills, willing to share and receive information and ideas at all levels of the organization.
High ethics and professional conduct.
Inclusive and collaborative mindset, stepping up to responsibility and making tough decisions while being accountable.
Results‑oriented team player with strong interpersonal skills, capable of working collaboratively with colleagues.
SCHEDULE
This is a salaried position, requiring at least 40 hours per week. Projects may require work beyond the standard hours.
Compensation & Benefits
Base salary range: annual amount determined based on experience, knowledge, and abilities.
Discretionary annual bonus based on a percentage of the employee's base salary.
Benefits include health, vision, dental, life insurance, 401(k) with employer match, and paid time off.
Company stock options.
Geneoscopy's Core Values
Integrity - we do the right thing through our words, actions, and behaviors.
Courage - step up, speak up, stand out.
Agility - think and act fast, embracing change.
Passion - for our customers, our people, our work, and for excellence.
Collaboration - our differences are assets.
Physical Demands
Employees may be required to lift routine office supplies and use standard office equipment.
Must be able to sit and/or stand for long periods.
Must be able to perform repetitive motion.
Work Environment
May have exposure to fumes and bio‑hazardous material in the laboratory environment.
May be required to handle blood‑borne pathogens and general laboratory reagents.
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