QA Associate II, Compliance
Bristol, PA
Quality – Quality Assurance /
Full Time /
On-site
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 Quality Assurance Associate is responsible for supporting site Quality leadership and ensuring that management of GMP documentation within the site maintained in a state of compliance with Global Quality policies and procedures and ensuring compliance with site Quality policies, procedures, industry best practices and global Regulatory standards.
- Supports management of the company’s eDMS (ZenQMS) as an associate within the Bristol site, maintains document master files, organizes central files with archived records and other Quality Assurance (QA) documents.
- Coordinates and controls document review, revision and approval workflows for documentation that is controlled within Abzena’s eDMS.
- Monitors records created with within the system for conformance to global requirements for document content and format.
- Works with line management and ZenQMS administrators to identify and implement opportunities to improve processes that enable efficient workflows within the system.
- Facilitates the review, processing, and maintenance of records withing the global eDMS through:
- Organization, maintenance, and archival of controlled documents.
- Writing, reviewing/revising, approving, and processing of system documents utilizing the eDMS.
- Issuance of controlled documents
- Issuance and review of electronic and paper based GMP logbooks.
- Communicates effectively to line management, escalates issues effectively and coordinates cross-functionally to facilitate implementation of solutions
- Maintains the status of document control workflows to drive on-time completion.
- Maintains documentation associated with the training program.
- Generates accurate and timely metrics aligned with required content and format of department/site KPIs.
- Provides new hire training to facilitate ZenQMS training.
- Perform other duties as assigned.
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
