Supervisor QC Reagent

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

KNOWLEDGE, SKILLS AND ABILITIES

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

Compensation Total Rewards

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, qualificatio…