Sr QA Associate

Abzena Inc.•Bristol, PA

11d

About The Position

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. 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.

Requirements

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.

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 inspectionâreadiness and regulatory compliance.
Identifies and resolves quality issues with crossâfunctional 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 Abzenaâs business.
Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
Operates to the highest ethical and moral standards.