Sr. Specialist, Quality Systems

Role Overview

The Sr. Specialist, Quality Systems plays a crucial role in reviewing and managing Quality Management System discrepancy reports and Corrective and Preventative Action (CAPA) records. They also contribute to the creation and revision of controlled and project documents, ensuring compliance with regulatory requirements.

Responsibilities

• Author, review, edit, and approve discrepancy reports including deviations, calibration exceptions, OOS results, and OOL results.
• Ensure discrepancy reports meet procedural and regulatory requirements, including root cause analysis and impact assessment.
• Author, review, edit, and approve CAPA records, ensuring they meet procedural and regulatory requirements.
• Author, review, edit, and approve controlled documents such as SOPs, forms, and BPRs.
• Participate in the generation and revision of controlled and project documents, including procedures, methods, and forms related to quality systems and product manufacture/testing.
• Interact with interdepartmental contacts on discrepancy reports, CAPA records, controlled documents, and other Quality topics.
• Represent Quality on multi-disciplinary teams.
• Maintain a state of inspection readiness and participate in inspection preparation activities.
• Provide assistance to internal and external customers in support of departmental functions.
• Collaborate with Management to establish and meet targets and timelines.
• Independently manage competing priorities with limited instruction.
• Follow company policies and procedures.
• Perform other duties as assigned by management.

Qualifications

• Bachelor's or Master's degree in a life sciences field (preferably).
• Minimum of 4-5 years of experience in the biopharmaceutical industry (preferably with biologics).
• Knowledge of cGMPs or equivalent regulations.
• Ability to interpret Quality standards for implementation.
• Skills to independently evaluate situations and propose potential solutions.
• Excellent technical writing and editing skills.
• Progressive experience with deviation records.
• Experience using quality systems software (quality management systems and/or electronic document management systems).

Position Details

This role is a full-time onsite position. Days of work are Monday through Friday, 8:00am to 5:00pm PST unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.

The compensation range for this role is $42.19 to $56.05 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

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.