Manufacturing Compliance Analyst

We are seeking an experienced Manufacturing Compliance & Technical Operations Specialist to support pharmaceutical/biopharmaceutical manufacturing operations in a regulated GMP environment. This role will focus on troubleshooting technical issues, managing deviations, driving CAPA actions, supporting investigations, and ensuring production activities remain compliant with cGMP and site quality standards.

The ideal candidate will have prior experience in biologics manufacturing, cleanroom operations, investigations, and cross-functional support within a fast-paced manufacturing setting.

Key Responsibilities

• Support daily manufacturing operations by resolving technical and compliance-related issues.
• Lead or support deviation investigations, root cause analysis, and corrective/preventive actions (CAPA).
• Review and approve change controls, controlled documents, and technical assessments.
• Partner cross-functionally with Quality, Facilities, Maintenance, Engineering, Calibration, EH&S, and Operations teams.
• Troubleshoot manufacturing process issues and implement sustainable solutions.
• Ensure operations comply with cGMP, FDA, ICH, and internal quality standards.
• Support contamination control, cleanroom investigations, and environmental monitoring excursions.
• Track actions to closure and maintain timelines for investigations and quality records.
• Assist during internal audits, inspections, and regulatory interactions.
• Author or revise SOPs, technical reports, and manufacturing documentation.
• Identify process improvement opportunities to increase compliance and operational efficiency.

Qualifications

• BS/BA degree in Life Sciences, Engineering, Biotechnology, or related field.
• 5+ years of experience in pharmaceutical, biotech, or biopharmaceutical manufacturing.
• Strong knowledge of cGMP regulations and quality systems.
• Experience with deviations, CAPA, investigations, and change control.
• Experience supporting biologics manufacturing:
• Mammalian Cell Culture (Upstream), and/or
• Purification / Downstream Processing
• Experience in cleanroom / aseptic manufacturing environments preferred.
• Strong technical writing and documentation skills.
• Ability to work independently and manage multiple priorities.
• Proficiency in Microsoft Office (Word, Excel, Project).

Preferred Experience

• FDA / regulatory inspection readiness
• Root Cause Analysis tools
• Environmental monitoring / contamination investigations
• GMP manufacturing support in biologics facilities

Work Environment

• GMP manufacturing / cleanroom environment
• Required gowning: scrubs, bunny suit, gloves, safety shoes
• Onsite support of manufacturing operations