Manufacturing Compliance Specialist I

Position Summary

The Manufacturing Compliance Specialist I ensures compliant and reliable cell therapy manufacturing through leadership of manufacturing compliance activities including deviation investigations, CAPA implementation, manufacturing documentation, validation support, technology transfer, inspection readiness, and continuous improvement. The role works within approved procedures, partners with the Quality Unit and other site functions, and escalates product, process, safety, and data integrity concerns promptly.

Schedule: This position is onsite 5 days a week, Monday - Friday, between our Burlington, MA office and our Cambridge office.

Key Responsibilities

Quality Management System

• Independently lead routine and moderately complex manufacturing deviation investigations, determine immediate and contributing causes using approved investigation methodologies, develop technically sound corrective actions, and escalate complex or cross-functional events as appropriate.
• Own assigned deviation, CAPA, and change control records from initiation through closure, ensuring investigations, effectiveness checks, and documentation are completed within established timelines.
• Apply approved root cause and human performance tools.
• Support product, process, equipment, facility, validation, and data impact assessments with Manufacturing and Quality subject matter experts.
• Follow current Good Manufacturing Practice, Good Documentation Practice, site procedures, and data integrity requirements when creating, reviewing, correcting, or approving records.

Manufacturing Documentation and Systems

• Author and independently revise manufacturing procedures, batch records, forms, and work instructions while assessing impacts to training, validation, and controlled documentation.
• Support document periodic review and change implementation to include training impact.
• Use applicable manufacturing and quality systems such as MES (EBR), ERP, advanced planning, electronic document management, and eQMS in accordance with access, security, and record control requirements.

Manufacturing Support and Process Improvement

• Perform routine manufacturing compliance assessments, identify procedural or execution gaps, recommend corrective actions, and partner with functional leaders to implement sustainable improvements.
• Support troubleshooting by collecting process information, reviewing available data, and coordinating subject matter input without making unauthorized process changes.
• Contribute to Lean and continuous improvement activities while preserving validated state, change control requirements, and product quality controls.
• Analyze recurring deviation trends.
• Identify systemic process weaknesses.
• Lead or co-lead continuous improvement initiatives.
• Use manufacturing metrics to prioritize improvement opportunities.
• Support implementation of process robustness improvements.

Training and Inspection Readiness

• Maintain personal training and role qualification in a current state.
• Coordinate assigned inspection readiness activities, prepare manufacturing documentation, respond to auditor requests, and support regulatory inspections as a manufacturing subject matter resource.
• Provide guidance to manufacturing personnel regarding documentation practices, deviation investigations, and GMP compliance.

Qualifications, Education, and Experience

Basic Qualifications

• BA/BS in a scientific discipline or equivalent experience preferred.
• 3-5 years of experience in a biopharmaceutical manufacturing environment.
• Familiarity with computer systems such as OpCenter, ERP, MES, EBR, and Veeva.
• Must be familiar with biopharmaceutical equipment and manufacturing systems.
• Knowledgeable of Current Good Manufacturing Practices and regulatory requirements.
• Excellent communication skills, written and verbal.
• Organizational and planning skills and the ability to cooperate with others in a team environment.
• Experience with Microsoft Office.

Preferred Qualifications

• Experience in cell therapy, biologics, aseptic processing, or another high-complexity manufacturing environment.
• Lean Six Sigma Certification or Experience.
• Root Cause Analysis, GEMBA Problem Solving, or equivalent certification or experience.
• Experience with Human Error Prevention Programs (HEPP).
• Basic laboratory skills, including working with mammalian cell culture.
• Experience working in an ISO 7 cleanroom environment.

Working Conditions & Physical Demands

• Ability to gown and gain entry to manufacturing areas.
• Ability to work On-Call weekend coverage on a rotating basis or as required.
• Rotating holiday coverage.