QA Associate I/II, Compliance

Abzena Inc. • Bristol, PA

4d • Onsite

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.

Requirements

• BS/BA degree or related work experience in document management activities preferred.
• Preferred minimum one (1) to three (3) years’ experience in a GMP oriented environment and Quality Assurance.
• Ability to work independently, multi-task, is organized, detail oriented and has good communication skills.
• Must have the ability to give presentations and train others.
• Knowledge of GMP regulations, ALCOA principles, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
• Must be familiar with Microsoft Office applications.
• Operates to the highest ethical and moral standards.
• Exhibits professional behavior with both internal and external business associates that reflect positively on the company and is consistent with the company’s policies and practices.

Responsibilities

• Participates in the planning, execution, and reporting of internal audits to assess compliance with quality systems and regulatory requirements
• Conducts routine GMP walkthroughs of manufacturing, laboratory, and warehouse areas to verify adherence to cGMP, GDP, and internal procedures, and identify gaps
• Executes and supports the site training program, including administration, tracking, and ensuring compliance with training requirements
• Supports document control operations within the eDMS (ZenQMS), including document lifecycle management, controlled document issuance, and archival in accordance with Global Quality and site procedures
• Coordinates document review, revision, and approval workflows within the eDMS to maintain documents in a state of control
• Performs QA review of GMP documents and records to ensure accuracy, completeness, and compliance with cGMP and GDP requirements
• Generates and tracks quality metrics to support site KPIs and continuous improvement initiative
• Perform other duties as assigned to support quality and compliance initiatives of the site.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree