Avid Bioservices · 2 days ago
Specialist (Lot Disposition), Quality Assurance
Tustin, CA
Full-time
Onsite
Entry, Mid Level
$27/hr - $36.78/hr
2+ years expAvid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of clients and improve patient outcomes. The Quality Assurance Specialist will be responsible for maintaining inspection readiness, collaborating with management, and serving as a quality representative on cross-functional teams to ensure compliance with cGMP regulations.
BiotechnologyHealth CareMedical
Responsibilities
Maintain a state of inspection readiness
Provide input to the development of personal performance goals and departmental objectives
Collaborate with Management to establish and meet targets and timelines
Serve as a Quality representative on cross-functional and multi-site teams
Identify and recommend solutions to potential procedure, process and system gaps
Provide assistance to customers in support of departmental functions
Participate in the design and implementation of department and cross-functional initiatives
Apply basic theory and technical principles to address moderately complex problems
Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships
Serve as a technical subject matter expert (SME) in support of department functions
Sign documents for activities as authorized and described by company policies, procedures and job descriptions
Review Manufacturing Batch Production Records
Review of Manufacturing forms and paperwork in association with Batch Production Records
Assist in the release of API batches and lots
Assist with discrepancy investigations
Compilation and QA Review of all records in Batch history records
Review of testing documentation from Microbiology and Chemistry groups
Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product
Represent Quality Assurance on multi-disciplinary project teams
Write and assist with excursion reports
Interact with interdepartmental contacts on discrepancy assessment, resolution and quality approval
Provide Quality oversight to internal and external customers
Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs
Generate departmental performance metrics for review by management
Perform assigned tasks and work to achieve company goals and department objectives by following company policies and procedures
Qualification
Required
B.A. or B.S. degree (preferably in the life science disciplines)
At least 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
Able to interpret quality standards for implementation
Benefits
Health, dental, and vision insurance
401(k) matching
Paid time off
Company
Avid Bioservices
Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine.
201-500 employees
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 CompanyTotal Funding
$285M2024-11-06Private Equity
2024-11-06Acquired
2024-03-06Post Ipo Debt· $160M
Leadership Team
Kenneth Bilenberg
President & Chief Executive Officer
Recent News
2025-11-13
2025-11-10
Company data provided by crunchbase