GMP Operations Supervisor jobs in United States
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Capricor Therapeutics, Inc. · 8 hours ago

GMP Operations Supervisor

Capricor Therapeutics is focused on operational excellence within their GMP environment. The GMP Operations Supervisor is responsible for managing equipment validation, calibration, and preventive maintenance schedules while ensuring compliance with quality standards.

BiotechnologyHealth CareMedicalTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Oversee and manage GMP Operations engineers on validation best practices, execution and documentation
Maintain and update calibration and preventive maintenance (PM) schedules for GMP-controlled equipment
Execution of equipment validation and re-validation activities in coordination with our Quality Engineering Team
Support the induction and documentation of controlled assets in alignment with compliance requirements
Coordinate daily, weekly, and monthly facilities tasks to ensure uninterrupted operations
Schedule PM and calibration activities with external vendors and collaborate with internal teams to minimize operational impact
Partner with Quality Assurance (QA) on vendor qualification and compliance verification
Work closely with Quality Engineering to ensure timely completion and closure of equipment-related work orders
Communicate with vendors for troubleshooting and repair needs, ensuring swift resolution
Assist in managing quality records, including deviations, CAPAs, and change controls related to GMP operations and facilities
Contribute to the revision and upkeep of equipment documentation and SOPs
Ensure all activities adhere to GMP regulations, internal policies, and industry best practices

Qualification

GMP regulationsEquipment validationCalibration processesQuality management systemsOrganizational skillsCommunication skillsProblem-solving skillsCollaboration skills

Required

Bachelor's degree in Engineering, Life Sciences, or a related field preferred; equivalent experience considered
Familiarity with GMP regulations and standards governing equipment and facilities operations
Basic understanding of calibration and maintenance processes for controlled equipment
Strong organizational and time-management skills with the ability to prioritize multiple tasks
Excellent communication and coordination skills for effective vendor and team interactions
Ability to work independently while maintaining a collaborative approach
Detail-oriented with strong problem-solving capabilities
Comfortable operating in a fast-paced, highly regulated environment

Preferred

Experience with quality management systems or documentation processes is a plus

Company

Capricor Therapeutics, Inc.

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Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.

H1B Sponsorship

Capricor Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$329.5M
Key Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M

Leadership Team

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AJ Bergmann
Chief Financial Officer
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Company data provided by crunchbase