Specialist; Lot Disposition), Quality Assurance

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.

• 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.