Principal Associate I, Batch Release Quality Assurance

Overview

This position will be required to interact with all departments within the company and to proactively support GMP compliance. The role provides an opportunity to enhance quality skills and experience within a GMP environment.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Responsibilities

Key responsibilities:

• Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure inspection readiness.
• Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration, marketing authorization and all other applicable requirements through review of testing records, investigations, non-conformances and out-of-specifications as part of the batch release process.
• Provide batch disposition and subsequent release and issuance of Certificate of Analysis/Conformance.
• Coordinate cross-functional activities associated with batch release, ensuring corrections are completed and associated batch documentation and investigations are closed out in a timely manner.
• Responsible for final approval and authorization of finished product for shipment and subsequent approval of packaging events.
• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Drive improvement of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
• Collect and provide input to and communicate performance metrics and data trends to Management for Batch Release related activities.
• Participate in the Change Control Review Board as needed.
• Interface and provide support to internal customers.
• Participate in Risk assessments.
• Provide QA input and approvals to assist in and drive projects as needed.

Other responsibilities

• Drafts, reviews, provides oversight to content, and approves controlled documents which may include but is not limited to standard operating procedures, validation documents, material specifications, etc.

Qualifications

Experience and skill requirement:

• 4-5 years of quality experience in biopharmaceutical industry.
• Strong written and verbal communication skills to interact with other functions.
• Adaptable, flexible, and able to manage change.
• Demonstrate strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.
• History of decision making leading towards continuous improvement

Location: 

This position is based in our Framingham location and typically has a 5-day on-site expectation.