Specialist, Quality Assurance (Early Phase)

Avid Bioservices • Costa Mesa, CA

7d • Onsite

About The Position

The Quality Assurance Specialist (Early Phase) is an individual contributor who addresses a variety of issues in accordance with cGMP regulations and company standards and helps maintain inspection readiness. The role serves as a Quality representative on cross-functional and multi-site teams, contributes to departmental and cross-functional initiatives, and provides technical subject matter expertise and Quality oversight to internal and external customers.

The Specialist reviews manufacturing batch production records, related forms and paperwork, batch history records, and testing documentation from Microbiology and Chemistry. The role assists with API batch and lot release, discrepancy investigations, excursion reports, and the review and approval of controlled documents related to product manufacturing processes, equipment, facilities, and utilities. The position works with other departments to assess and resolve discrepancies, execute review activities efficiently under applicable SOPs, and generate departmental performance metrics. This is a full-time onsite role, generally Monday through Friday, with overtime and/or weekend work as necessary.

Requirements

• B.A. or B.S. degree, preferably in a life science discipline.
• At least 2 years of experience in the biopharmaceutical industry.
• Knowledge of cGMPs or equivalent regulations.
• Ability to interpret quality standards for implementation.
• Ability to independently evaluate situations and propose potential solutions.
• Strong written and verbal communication skills.
• Exceptional multitasking skills and attention to detail.
• Ability to build relationships with team members, clients, vendors, and suppliers.
• Ability to work overtime and/or weekends when necessary.
• Ability to perform regular sitting, standing, and walking, and occasionally lift objects up to 25 pounds.
• Visual acuity, including close, distance, and color vision.

Responsibilities

• Maintain a state of inspection readiness.
• Provide input to personal performance goals and departmental objectives, and collaborate with Management to meet targets and timelines.
• Serve as a Quality representative on cross-functional, multi-site, and multidisciplinary project teams.
• Identify and recommend solutions to potential procedure, process, and system gaps.
• Provide assistance to customers in support of departmental functions and provide Quality oversight to internal and external customers.
• Participate in the design and implementation of department and cross-functional initiatives.
• Apply technical principles to address moderately complex problems and troubleshoot and initiate resolution of Quality issues through interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert in support of department functions.
• Sign documents for activities as authorized by company policies, procedures, and job descriptions.
• Review Manufacturing Batch Production Records and related manufacturing forms and paperwork.
• Assist in the release of API batches and lots.
• Assist with discrepancy investigations and compile and perform QA review of batch history records.
• Review testing documentation from Microbiology and Chemistry groups.
• Review and approve controlled documents relating to processes, equipment, facilities, and utilities used in product manufacture.
• Write and assist with excursion reports.
• Interact with other departments on discrepancy assessment, resolution, and Quality approval.
• Collaborate with departments to ensure review activities are completed efficiently according to governing SOPs.
• Generate departmental performance metrics for management review.
• Perform assigned tasks and work toward company goals and department objectives in accordance with company policies and procedures.

Benefits

• Competitive compensation package with base salary and performance-based bonuses.
• Health insurance.
• Dental insurance.
• Vision insurance.
• 401(k) matching.
• Paid time off.
• Career growth and development opportunities.
• Supportive and inclusive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level