Supervisor QC Reagent

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required.

POSITION SUMMARY   The Supervisor, QC Reagent will manage day-to-day operations of formulation 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

• Receives predetermined work assignments that are subject to a moderate level of control and review.
• Directs employees to complete assignments using established guidelines, procedures and policies.
• Responsible for day-to-day operational staffing, including hiring/training of personnel.
• Provides direction to employees according to established policies and management guidance.
• Administers company policies that directly affect employees.
• Recommends changes to unit or sub-unit policies.
• Provides direct supervision to professional individual contributors and/or skilled, support individual contributors
• Supervision of quality control testing and incoming material inspection in a highly regulated environment (CLIA/CAP/ISO13485).
• Responsible for day-to-day staffing/scheduling/setting up sample run schedules.
• Ensures production work is consistently completed according to department goals.
• Ensures all reagents are processed and accounted for.
• Monitor team members to ensure adherence to SOPs and safety procedures
• Oversees training for new hires: works in conjunction with lead to train new hires.
• Investigates/follows up on lab errors and reagent QC failures (NCR).
• Assists manager in initiating and completing CAPAs.
• Handles employee issues. Collaborates with Manager to resolve issues.
• Ensures alignment with team for reasoning behind instructions/processes, changes that are made, why certain ideas cannot be implemented effectively.
• Meets regularly with individual team members to discuss goals and progress.
• Responsible for staff performance reviews.
• Plans and leads shift meetings
• Keeps team morale up and maintains professionalism of team members, including by acting as role model.
• Ensures compliance with all regulatory agency requirements through documentation, audits, and corrective action.
• Go-to person when manager is not present.
• May assist lab team in day to day tasks and lab work if necessary.
• Approves timecards and PTO requests
• Escalates lab issues and team concerns to manager. Communicates the problem and suggests possible solutions.
• Understands the entire lab process and is able to identify and troubleshoot issues when they arise.
• Understands when and how to escalate issues appropriately.
• Makes sure the goals set by manager for the team are being met in the lab.
• Performs and completes side projects assigned by the manager.
• Able to take on own projects with little supervision.
• Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, and Support.
• Assisting in the transfer of new products/processes into the clinical laboratory with RND and Process Development Teams.
• Assist in gathering and providing monthly consolidation of OPS-RGT Metrics.
• This role works with PHI on a regular basis both in paper and electronic form and have an 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.
•  Performs other duties as assigned.

QUALIFICATIONS

• 6+ years of industry-related experience
• BS/BA degree (or equivalent) in Biological Sciences or related field
• License is preferred :Current California CLS license or CGMBS license (Clinical Genetics Molecular Biology Scientist).

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 complian