Job Description
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 Associate (I/II), QA Compliance is responsible for supporting site compliance and ensuring that GMP document control is maintained in a state of control in accordance with Quality policies and procedures, industry best practices, and applicable global regulatory standards.
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.
Qualifications
- 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.
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
