Supervisor QC Reagent

About this role

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.

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Perform, troubleshoot and follow up incoming inspection, manufacturing and Quality Control tests for reagent release

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Support and leads development of workflow troubleshooting and procedure improvements

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Escalate issues/concerns and suggests possible solutions and collaborates with Manager to resolve issues

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Knowledgeable & competent in Reagent Team Benchwork & Data Analysis

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Support and provide approvals for QC documentation updates

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Oversee and maintain training records for new hires

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Implement new process changes, tech transfers, planning workflow and reagent preparation and qualification.

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Provide direction and guidance to employees

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Provide direction for planning meetings to meet Turnaround time (TAT) to ensure work is consistently completed according to department goals.

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Assist with Audit preparation by compiling data and prepares reports as needed.

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Lead Continuous Improvement Projects

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Participate in the preparation of investigations, summaries, and reports

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Assist in maintaining, updating, and approving documents pertaining to raw material specifications, reagent qualification, laboratory procedures, and department training

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Perform Record Review of Incoming Inspection, Manufacturing, Qualifications, Maintenance Log, etc

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Responsible for day-to-day operational staffing, including hiring/training of personnel.

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Administer company policies and management guidance that directly affect employees.

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Meet regularly with individual contributors to discuss goals and performance.

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Keep team morale up and maintains professionalism of team members.

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Able to take on own projects with little supervision.

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Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, Support and Product Development.

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Follow/Ensure GLP (good laboratory practices) and GMP (good manufacturing practices) compliance

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Conduct self in a Professional manner

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Perform other duties as assigned

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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…