Document Control Manager
2 days ago
Abzena is seeking a highly skilled Document Control Manager to join our team. As a key member of our Quality Assurance department, you will be responsible for leading the Document Control and Training teams and functions.
Key Responsibilities:
- 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
- Directly lead and perform, execute, and assist in the execution of daily tasks in the Document Control and Training areas
Requirements:
- BS/BA degree, preferably in science
- Minimum Seven (7) years of experience in Quality Assurance within a GMP oriented/regulated environment
- Three (3) to Five (5) years of direct people leadership experience
- Demonstrated ability to perform under pressure, work independently, multi-task, and organizational skills
- Excellent written and verbal communication skills
- Experience in regulatory/health authority inspections, client and internal audits
- Knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, EU GMP, and other applicable regulations, standards, and guidance
- Demonstrated ability to successfully interface and collaborate with a multi-discipline team
- Must be familiar with Microsoft Office applications
What We Offer:
- $100,000 - $150,000 a year
- Exempt status
- Equal opportunity employer committed to diversity and inclusion
About Abzena:
Abzena is a responsible and dedicated partner that takes care of your products from concept to patient. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
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