Specialist (OTF), Quality Assurance jobs in United States
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Avid Bioservices · 6 hours ago

Specialist (OTF), Quality Assurance

Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to improve patient outcomes. The Quality Assurance Specialist will ensure quality oversight for clinical and commercial cell therapy operations, ensuring adherence to Good Manufacturing Practices and supporting right-first-time execution on the production floor.

BiotechnologyHealth CareMedical
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H1B Sponsor Likelynote

Responsibilities

Provide quality oversight of production floor to ensure manufacturing operations adhere to GMP and GDP requirements, including data integrity
Observe manufacturing operations and identify departures from clean room behaviors, aseptic techniques, and applicable procedures through process observations
Perform real-time review of executed batch records and manufacturing test forms to ensure compliance with procedures
Collaborate with Manufacturing teams to resolve discrepancies on-the-floor
Ensure timely escalation of any discrepancies to management
Provide support during regulatory inspections and other audits; maintain a state of inspection readiness
Perform other duties as assigned by Quality Assurance management

Qualification

CGMP knowledgeBiopharmaceutical experienceQuality standards interpretationData integrity principlesMultitasking skillsCommunication skillsRelationship buildingAttention to detail

Required

Bachelor's degree (preferably in the Life Sciences)
2+ years of experience in the biopharmaceutical industry
Knowledge of CGMPs or equivalent regulations
Ability to interpret quality standards for implementation
Skills to independently evaluate situations and propose potential solutions

Benefits

Health, dental, and vision insurance
401(k) matching
Paid time off

Company

Avid Bioservices

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Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine.

H1B Sponsorship

Avid Bioservices 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
2025 (2)
2024 (1)
2023 (1)
2022 (5)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$285M
2024-11-06Private Equity
2024-11-06Acquired
2024-03-06Post Ipo Debt· $160M

Leadership Team

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Kenneth Bilenberg
President & Chief Executive Officer
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Company data provided by crunchbase