Manager, Manufacturing Quality Systems

Avid Bioservices • Tustin, CA

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About The Position

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 Manager, Manufacturing Quality Systems position is responsible for overseeing and coordinating the activities of the Manufacturing Quality Systems (MQS) group. They will collaborate with their team in writing records for Avid’s Quality Management System (QMS) including, but not limited to, records for the following: Deviations, out-of-tolerance calibration events, out-of-specification (OOS) results, out-of-limit (OOL) results, and out-of-trend (OOT) results. This role coordinates and participates in investigations required to write these records and routing/tracking records from assignment to approval. Identifies and implements corrective and preventive actions (CAPAs), as applicable. Where issues or improvements are identified, this role works with subject matter experts to propose viable solutions including a final product impact assessment. Identifies and implements solutions for elements that can be made more efficient, are potential sources of discrepancies, require ‘fine-tuning’, or need a complete revision.

Requirements

• Related bachelor’s degree (i.e. Biology, Biotechnology, Chemical Engineering)
• 4+ years of cGMP purification experience
• 1+ years of leadership experience or equivalent

Responsibilities

• Adheres to Good Manufacturing Practice (GMP) regulations (21 CFR, Part 211) and Good Documentation Practices (GDP), as applicable.
• Identifies technical, procedural, and equipment issues that hinder production and compliance, and improves the manufacturing processes.
• Leads and conducts root cause investigations for a variety of events, with reference to related source documents including, but not limited to, procedures, protocols, reports, batch records, laboratory data, and calibration data; apply relevant scientific and technical principles during investigation.
• Write QMS records with excellent attention to detail; ensure records accurately present the facts determined during investigation.
• Coordinates and plans for the implementation of new procedures, processes, and equipment to be used in Manufacturing.
• Designs and conducts small scale studies to support GMP compliance of manufacturing processes and deviation root cause investigations.
• Analyzes process data, writes technical reports and makes technical recommendations/presentations.
• Proactively interface with witnesses and subject matter experts to gather information; interface with Quality Assurance (QA) on questions related, but not limited to: GMP compliance, Avid procedures and processes, investigation requirements, and record quality and style.
• Manage each record from the time it is assigned through closure; work with all stakeholders to ensure record is closed according to defined timelines.
• Performs specific assignments as requested by VP of Operations.
• Perform other duties as assigned.

Benefits

• We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
• Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 101-250 employees