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Specialist (Lot Disposition), Quality Assurance
Avid BioservicesUnited Statesfull_timeVerifiedPosted 25 Nov 2025
💰 $72,000/yr($54,000/yr – $72,000/yr)
About the role
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Quality Assurance Specialist (On the Floor) is an individual contributor who will solve a variety of issues following cGMP regulations and company standards.
- 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.
- 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.
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