Supv, QC Equipment

POSITION SUMMARY:

The Supervisor, QC Equipment will manage day-to-day operations of maintenance, qualification, and support of laboratory equipment to support production. Works closely with manager to ensure company and team goals are met. Ensures quality work is completed timely.

PRIMARY RESPONSIBILITIES:

• Responsible for day-to-day operational staffing, including hiring/training of personnel, and scheduling of work.

• Provides direct supervision to professional individual contributors and/or skilled, support individual contributors.

• Directs employees to complete assignments using established guidelines, department goals, procedures, and policies

• Ensures compliance with all regulatory agency requirements through documentation, audits, and corrective action.

• Investigates/follows up on lab errors and equipment related non-conformance (NCR) and corrective action plan (CAPA).

• Provides direction to employees according to established policies and management guidance;  administer company policies that directly affect employees.

• Understands when and how to escalate issues appropriately.

• Escalates lab issues and team concerns to manager.

• Communicates the problem and suggests possible solutions.

• Keeps team morale up and maintains professionalism of team members, including by acting as role model.

• Meets regularly with individual team members to discuss goals and progress.

• Responsible for staff performance reviews.

• Plans and leads shift meetings

• Assist in gathering and providing monthly consolidation of OPS-Equipment Metrics.

• Handles employee issues.

• Collaborates with Manager to resolve issues.

• Go-to person when manager is not present.

• Approves timecards and PTO requests

• Performs and completes side projects assigned by the manager.

• Actively interacts with external service vendors and interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, and Support.

• Purchases instrumentation to support production assays.

• Provides support, technical knowledge, and resource to team members to diagnose, service, and maintain all lab equipment and instruments.  

• May assist team in day to day tasks if necessary.

• Develops and executes maintenance and qualification procedures for new and/or returning laboratory instrumentation in accordance with design requirements, operational needs, and applicable standards.

• Revises and create departmental equipment procedures as needed. 

• Identifies and leads process improvement changes as needed.

• Performs other duties as assigned.

• Adherence to CLIA/CAP/ISO13485 regulations as it pertains to instrumentation and equipment.

• This role works with PHI on a regular basis both in paper and electronic form and has 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:

• BS/BA in Engineering / Science or equivalent independent experience servicing and repairing complex laboratory instrumentation.

• 5+ years of industry related experience.

• Proven experience supporting automation and sequencing instrumentation required.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong leadership skills.

• Ability to analyze and problem solve issues.

• Excellent attention to detail and accuracy.

• Ability to promote a positive team environment

• Candidate must be a self-starter who can independently drive projects and day-to-day work tasks to completion according to schedule. 

• Adaptability in a frequently changing environment.

• Maintain a high level of professionalism and responsibility.

• Good technical writing and strong oral and written communication skills.

• Must have strong interpersonal and organizational skills.

• Word processing and data management skills.

• Knowledge of DNA Isolation and Purification, PCR, Sequencing, etc.

• Experience with Tecan and Hamilton automation and Illumina sequencing platforms preferred.

• Calibration and metrology experience.

• Experience in a regulated environment, CLIA/CAP/ISO1348