Supervisor QC Reagent

United States·San Carlosmid

OtherSupervisor

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Quick Summary

Overview

POSITION SUMMARY The Supervisor, QC Reagent will manage day-to-day operations of manufacturing and testing of consumable reagents to support production.

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OtherSupervisor

POSITION SUMMARY

The Supervisor, QC Reagent will manage day-to-day operations of manufacturing and testing of consumable reagents to support production. Works closely with Manager to ensure company and Team goals are met. Ensure quality work is completed timely.

PRIMARY 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 leads development of workflow troubleshooting and procedure improvements
Escalate issues/concerns and suggests possible solutions and collaborates with Manager to resolve issues
Knowledgeable & competent in Reagent Team Benchwork & Data Analysis
Support and provide approvals for QC documentation updates
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
Provide direction for planning meetings to meet Turnaround time (TAT) to ensure work is consistently completed according to department goals.
Assist with Audit preparation by compiling data and prepares reports as needed.
Lead Continuous Improvement Projects
Participate in the preparation of investigations, summaries, and reports
Assist in maintaining, updating, and approving 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.
Keep team morale up and maintains professionalism of team members.
Able to take on own projects with little supervision.
Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, Support and Product Development.
Follow/Ensure GLP (good laboratory practices) and GMP (good manufacturing practices) compliance
Conduct self in a Professional manner
Perform other duties as assigned
Adhere to Departmental Expectations
This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job
Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire
Must maintain a current status on Natera training requirements

QUALIFICATIONS

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 SOP’s and QC documentation is preferred
For California site
- Current California State CLS or CGMBS license (Clinical Genetics Molecular Biologist Scientist) is required
For Texas site
- Current MT/MTS/CLS certification from ASCP, AMT, or AAB is required

Strong leadership skills
Normally receives no instruction on routine work, general instructions on new projects or assignments
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

PHYSICAL DEMANDS & 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

What We Offer

~2 min read

This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.

This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including:

✓Annual performance incentive bonus

✓Long-term equity awards

✓Comprehensive health benefits (medical, dental, vision)

✓401(k) with company match

✓Generous paid time off and company holidays

✓Additional wellness and work-life benefits

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.