Supervisor, Quality Control Reagent
2 days ago
The Supervisor, QC Reagent will oversee the day-to-day operations of manufacturing and testing of consumable reagents to support production. This role will work closely with the Manager to ensure company and team goals are met, ensuring quality work is completed timely.
Key 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 lead the development of workflow troubleshooting and procedure improvements.
- Escalate issues/concerns and suggest possible solutions and collaborate with the Manager to resolve issues.
- Knowledgeable and 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.
- 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.
- Current California State CLS or CGMBS license (Clinical Genetics Molecular Biologist Scientist) is required for California site.
- Current MT/MTS/CLS certification from ASCP, AMT, or AAB is required for Texas site.
- 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.
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