GMP QA Specialist: Batch Release & Compliance

Replimune-2; Framingham (MA); On-site; USD 106,000 - 137,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Holidays including year-end shutdown

Job summary

Replimune Group, Inc. in Massachusetts is seeking a Quality Assurance professional to support GMP compliance, batch release, and QA operations across departments.

You will partner with Regulatory, Clinical, and Manufacturing to ensure readiness for inspections, maintain the QMS, and drive continuous improvement through CAPA, change control, and document reviews. 3–5 years biotech/pharma QA experience required.

Qualifications

• A minimum of a formal degree; Associates plus applicable work experience may be considered.
• 3-5 years of quality experience in biotech or pharmaceutical industry.
• High level of attention to details and excellent time management.
• A very organised and methodical approach to tasks.
• Strong written and verbal communication skills to interact with other functions.
• IT skills – competent in using Microsoft Office.
• A level of flexibility is essential to meet varying workloads.

Responsibilities

• Provide supporting day-to-day operation of the Quality Assurance department to ensure the implementation and maintenance of Quality Management System (QMS) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies.
• Aid in preparation for inspection readiness and participate actively during inspections and audits.
• Perform batch release for GMP lots, including final Quality Review of associated quality records to ensure closure, preparation of associated batch release documentation to ensure completeness and accuracy in accordance with procedure. Prioritize batch release in support of business needs including maintaining batch release status and communicate release needs throughout the organization.
• Support the oversight 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.
• Assist in tracking and populating QMS metrics related to change controls, CAPAs and deviations.
• Conduct / participate in the Change Control Review Board
• Support vendor qualification process, issuance of vendor questionnaire and authoring of vendor quality technical agreements.
• Support supplier corrective action notification and request, vendor notification systems, when applicable.
• Review and approve Standard Operating Procedures (SOPs), Validation Protocols / Reports, Production Records, or GMP records, Testing Records and Engineering Drawings, ensuring internal and external standards are met.
• Interface and provide support to internal customers in Product Development, Quality Control Labs, etc., and, as appropriate, with external vendors to support ongoing compliance with Replimune requirements and quality standards.

Skills

Quality focus

Attention to detail

Time management

Organized

Communication skills

Flexibility

Education

Formal degree

Tools

Microsoft Office

Job description

Replimune Group, Inc. in Massachusetts is seeking a Quality Assurance professional to support GMP compliance, batch release, and QA operations across departments.

You will partner with Regulatory, Clinical, and Manufacturing to ensure readiness for inspections, maintain the QMS, and drive continuous improvement through CAPA, change control, and document reviews. 3–5 years biotech/pharma QA experience required.