QA Specialist - Military veterans preferred

Cambrex


QA Specialist

US-MA-Waltham

Job ID: 2025-4412
Type: Regular Full-Time
# of Openings: 1
Category: Quality Assurance
Cambrex - Waltham

Overview

Snapdragon Chemistry is currently seeking exceptional candidates for its Quality Assurance Specialist position. A successful candidate, reporting to the Quality Assurance Manager, will be joining a highly innovative and entrepreneurial team of engineers and scientists seeking to advance pharmaceutical development and manufacturing.

The QA Specialist will play a key role in supporting Snapdragon Chemistry's Quality Management System (QMS) and GMP operations. This role involves oversight of document control, training compliance, equipment lifecycle documentation, batch record review, lot disposition, and ongoing support for manufacturing and quality initiatives. The ideal candidate will ensure GMP standards are upheld across all stages of production and documentation.

We are looking for candidates who have a passion for the science of pharmaceutical manufacturing and excited to share the Snapdragon vision of future manufacturing. The ideal candidate will have at minimum a BS degree in scientific discipline and pharmaceutical quality assurance experience.

• Support the Quality Assurance function at Snapdragon Chemistry, a Cambrex company, to ensure compliance with cGMP and internal quality standards.
• Maintain and manage the Quality Management System (QMS) to meet regulatory and internal procedural requirements.
• Support document control activities including issuance, revision control, archival, and retirement of controlled documents.
• Oversee the training management system by ensuring training assignments are current and tracked for all applicable personnel.
• Assist with equipment lifecycle management, including initiation, qualification, and periodic review of equipment.
• Generate periodic reports and trend quality system data to support audits, inspections, and management reviews.
• Coordinate issuance of lot numbers and Master Batch Records (MBRs) to support GMP manufacturing activities.
• Review raw material documentation, batch records, and analytical data to ensure compliance and completeness.
• Perform lot disposition activities, including review and reconciliation of batch records, deviations, investigations, out-of-specification (OOS) reports, and preparation of final QA disposition documentation for client delivery.
• Facilitate release of manufacturing suites both pre- and post-cleaning for GMP operations.
• Coordinate in-process GMP document reviews with clients and manage client approval workflows.
• Interface with clients during audits, document reviews, and to address quality-related questions during project execution.
• Manage laboratory notebook lifecycle, including issuance, tracking, collection, auditing, and archival.
• Ensure compliance with data integrity principles (ALCOA) in lab documentation practices.
• Support execution of client and vendor qualification programs, including coordination of qualification documentation and audit activities.
• Assist with internal and external audit preparation, document retrieval, and audit responses.
• Participate in continuous improvement initiatives focused on enhancing quality systems and operational workflows.
• Assist with onboarding and QA training for new personnel.
• Perform other QA-related duties as assigned by QA leadership.

• BS degree in a scientific discipline

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