Specialist (Lot Disposition), Quality Assurance

About the role

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. The Quality Assurance Specialist (Lot Disposition) is an individual contributor who solves a variety of issues following cGMP regulations and company standards.

Responsibilities

• Perform assigned tasks and work to achieve company goals and department objectives by following company policies and procedures.
• 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.
• Independently manage competing priorities with limited instruction.
• 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.
• Perform tasks as requested by Management to support Quality oversight activities.
• Review of 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.
• 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.
• Other duties may be assigned.

Requirements

• Bachelor’s degree (preferably in Life Science).
• Minimum of 2 - 4 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.

Schedule

This is a full-time, onsite position with a regular work schedule of Wednesday through Saturday, 1:00 PM to 12:00 AM (four 10-hour shifts each week). Employees may be required to work overtime, weekends, holidays, or adjusted schedules as needed to support business operations.

Pay

The compensation range for this role is $32.69 - $40.86 hourly depending on experience and qualifications, including a base salary and performance-based bonuses.

Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) matching.
• Paid time off.
• Opportunities for career growth and development.
• Supportive and inclusive work environment.

Physical Demands & Work Environment

• Regular activities include sitting, standing, and walking.
• Occasional physically engaging tasks such as lifting objects up to 25 pounds.
• Potential exposure to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally.
• Reasonable accommodations are available to enable individuals with different abilities to perform effectively.
• Visual acuity, including close, distance, and color vision, is essential for navigating day-to-day demands.