Supervisor, Quality Control Reagent

3 weeks ago


San Carlos, California, United States Natera Full time
Job Summary

The Supervisor, QC Reagent will oversee the day-to-day operations of manufacturing and testing of consumable reagents to support production. This role works closely with the Manager to ensure company and team goals are met, with a focus on ensuring quality work is completed timely.

Key Responsibilities

Provide direct supervision and follow-up to individual contributors in a highly regulated environment (CLIA/CAP/ISO13485) to ensure adherence to SOPs and safety procedures.
Perform, troubleshoot, and follow up incoming inspection, manufacturing, and Quality Control tests for reagent release.
Support and lead the development of workflow troubleshooting and procedure improvements.
Escalate issues/concerns and suggest possible solutions, collaborating with the Manager to resolve issues.
Maintain knowledge and competence in Reagent Team Benchwork & Data Analysis.
Oversee and maintain training records for new hires.
Implement new process changes, tech transfers, planning workflow, and reagent preparation and qualification.
Provide direction and guidance to employees.
Assist with Audit preparation by compiling data and preparing reports as needed.
Lead Continuous Improvement Projects.
Participate in the preparation of investigations, summaries, and reports.
Maintain, update, and approve documents pertaining to raw material specifications, reagent qualification, laboratory procedures, and department training.
Perform Record Review of Incoming Inspection, Manufacturing, Qualifications, Maintenance Log, etc.
Responsible for day-to-day operational staffing, including hiring/training of personnel.
Administer company policies and management guidance that directly affect employees.
Meet regularly with individual contributors to discuss goals and performance.
Maintain team morale and professionalism.
Actively interact with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, Support, and Product Development.
Ensure GLP (good laboratory practices) and GMP (good manufacturing practices) compliance.

Requirements

4+ years of experience if degree is in CLS/MLS or 4.5+ years of experience if BS/BA degree (or equivalent) in Biological Sciences or related field is required.
Relevant Molecular Biology and/or Cell Culture experience in a laboratory setting is strongly preferred.
Experience with writing of SOPs and QC documentation is preferred.
Current California State CLS or CGMBS license (Clinical Genetics Molecular Biologist Scientist) is required for California site.
Current MT/MTS/CLS certification from ASCP, AMT, or AAB is required for Texas site.

Skills and Abilities

Strong leadership skills.
Strong interpersonal, communication, computer, troubleshooting, and pipetting skills.
Strong oral and written communication skills.
Word processing and data management skills.
Experience in PCR and other Molecular Biology Techniques.
Understanding of Quality Control methods development and implementation.
Supply chain, document control, and regulatory compliance experience.
Experience in a regulated environment, GMP, ISO, CLIA, CAP, and Aseptic techniques.

Work Environment

Must be able to lift up to 50lbs and perform laborious tasks.
Standing or sitting for long periods of time may be necessary.
Duties require exposure to cold air due to frequent accessing of refrigeration/freezer units.
This position requires the ability to use a computer keyboard, handheld scanning device, communicate via electronics, read materials, and use equipment in reagent preparation.
Duties are performed in a laboratory setting (ie. BSL-1, BSL-2, etc.) with potentially hazardous material and in an office setting.
Duties require wearing safety goggles, gloves, and lab coat.
Duties may require working outside shift working hours, evenings, weekends, holidays, and/or overtime.

Travel Required

No travel is required for this position.

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