Manager/Sr. Manager QC Lot Release

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Job description

About us: Lucira Health is a startup striving to transform the way infectious diseases are diagnosed. Lucira Health is the first at-home COVID test authorized by the FDA. Our technology is a single-use, user-friendly COVID-19 test kit that can produce a positive or negative result at home within 30 minutes. This technology bypasses centralized medical lab testing and streamlines patient care. Our current areas of focus include COVID-19 and influenza.

Job Title: Manager/Sr. Manager QC Lot Release

Location: Emeryville, CA

Description:

As Manager/Sr. Manager of Quality Control-Lot Release you will be responsible for leading the Quality Control-Lot release operations across 3 shifts, ensuring that devices pass final lot release testing, environmental monitoring and microbiology activities ranging from bioburden testing, root cause investigations to Equipment Control. This position reports to the Director of Quality.

Primary Job Function:

• Build infrastructure and streamline processes
• Lead a team in defining, developing, and executing appropriate procedures to standardize and streamline laboratory operations in compliance with quality requirements.
• Implement quality management process to meet requirements for final device and formulation lot release testing.
• Work cross-functionally with R&D, Operations, Regulatory, and EH&S leaders to ensure that appropriate procedures are established, and compliance is maintained to support product development.
• Exercise influence across functional teams and engage with internal and external stakeholders.
• Manage QC laboratory operations and oversee material and equipment procurement.
• Manage and develop QC Technicians and lab personnel.

Other Responsibilities:

• Schedule/Coordinate Lot release testing across 3 shifts in conjunction with planning.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
• Manage and own Non-conformance reports (NCR) and corrective and preventive actions (CAPA) related to QC Lab operations.
• Additional duties may be identified by functional management based on the current project/business objectives.

Requirements:

• A degree in the field of Molecular Biology, Bioengineering, or a related field with 5+ years relevant experience in lab operations for research, pharma, medical device or other relevant industry and a minimum of 3 years as a people manager.
• Demonstrated success implementing and managing laboratory operations, with the ability to meet organizational objectives and scale up capabilities to meet product development challenges.
• Experience managing facilities with BSL2 environments, including clinical sample procurement, handling, and tracking.
• Experience working within a regulated industry with strong knowledge or experience in GLP and FDA guidelines.
• A stellar multitasker able to deliver tasks and projects on time, keeping stakeholders informed throughout the process.
• Ability to learn new processes quickly and adapt to changing environments.
• Strong interpersonal skills with a proven ability to collaborate with others in a multi-disciplinary team setting, influence decision making, and build group consensus.
• Excellent collaboration, communication, and presentation skills.
• Familiarity with PCR & Sequencing techniques and laboratory automation a plus.
• Assay/Reagents manufacturing experience preferred

Lucira Health is an Equal Opportunity Employer

Individuals seeking employment at Lucira Health are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.