Supervisor QC Reagent

• 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

• 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

• 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