The Senior Associate, QA Operations is responsible for providing quality oversight of GMP manufacturing and development activities through direct quality presence on the manufacturing floor and review/approval of GMP documentation. This role ensures that manufacturing operations comply with cGMP regulations, internal procedures, and client requirements. The position serves as the primary QA partner to Manufacturing and Process Development teams, supporting batch execution, documentation review, deviation management, and real-time compliance oversight. The role requires strong knowledge of GMP requirements, attention to detail, and the ability to work cross-functionally in a fast-paced CDMO environment.
Responsibilities- Provides real-time QA oversight of GMP manufacturing operations, including on-floor support during processing of process intermediates and drug substance products.
- Guides batch execution to ensure compliant operations.
- Maintains inspection-readiness and regulatory compliance.
- Identifies and resolves quality issues with cross-functional teams.
- Reviews batch records, supporting data, and associated GMP documentation for timely and accurate batch disposition.
- Analyzes data trends to drive problem resolution and support continuous improvement initiatives.
- Contribute to quality improvement and lean initiatives.
- Oversees the site Environmental Monitoring (EM) program.
- Supports document control, training, audits, and systems.
- Demonstrate professionalism, integrity, and adherence to company policies and quality standards.
- Participates effectively as a team player in all aspects of Abzena's business.
- Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
- Operates to the highest ethical and moral standards.
Qualifications- Bachelor's degree in science or engineering or equivalent with 5-8 years of relevant experience in a GMP regulated Biopharmaceutical facility or equivalent.
- Relevant experience in Quality Assurance, Quality Operations, Quality Compliance, and GMP manufacturing.
- Adequate knowledge of GMP regulations (US, EU and ROW), good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
- Detail oriented with strong written and verbal communication skills. Must have the ability to give presentations and train others.
- Experienced in early-phase to commercial quality systems development and maintenance.
- Ability to work well under pressure, independently, multi-task, be organized and have good communication skills.
FLSA: Exempt
