QA Associate II, Compliance

Abzena Inc. • Bristol, PA

1d

About The Position

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.

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

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level