QA Training Manager

Overview

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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.

Responsibilities

• Directly responsible for leadership of the Document Control and Training teams and functions.
• Manage the document management and training program.
• Strategically partner with Quality leadership to facilitate short-term and long-term Quality initiatives.
• Collaborate with Quality leadership and departmental stakeholders to ensure accurate and timely delivery of documents and training to ensure regulatory, global, site, and departmental goals and requirements are maintained and met.
• Directly lead as well as perform, execute, and assist in the execution of daily tasks in the Document Control and Training areas.
• Operate in both a team and individual setting.
• Facilitate the review, processing, and maintenance of the global Document Control system through :
• Organization, maintenance, and archival of controlled documents.
• Writing, reviewing / revising, approving, and processing Standard Operating Procedure (SOP), Batch Record, Protocol, and equivalent documents through the Document Control system.
• Issuance of document, part, lot, and investigation numbers.
• Issuance and review of electronic and paper based GMP logbooks.
• Maintain the status of Document Control workflows to drive on time completion.
• Evaluate document management and training quality processes for continuous improvement.
• Provide Document Control and Training Quality metric as required.
• Update Quality Systems tracking tools as required.
• Assist in the QMS and CSV qualification activities as required.
• Conduct internal audits of the document control and training processes.
• Provide customer communication and customer audit processes related to document control.
• Collaborates with site personnel to drive consistency in quality process execution.
• Execute and maintain Electronic Management Systems as it relates to document control.

Manager Responsibilities

Qualifications

Compensation : $100,000 - $150,000 a year

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.

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