Quality System Documentation Specialist

AstraZeneca • Santa Monica, CA

3d • $65,557 - $98,335 • Onsite

About The Position

The Quality System Documentation Specialist is responsible for performing activities that directly support execution of site processes. The incumbent will support quality systems, with a focus on documentation and training process support. We are seeking a highly motivated individual to join us and assist with document processing and other duties related to the processing and archival of documentation. The successful candidate is proficient in communication (written and verbal), can multi-task, is a time-line focused and flexible in their work schedule. You will be expected to provide support for both the Santa Monica, CA and Tarzana, CA sites as needed.

Requirements

• High School diploma with up to 4 years of relevant experience is required. Relevant academic experience, coursework, or internships are a plus.
• Strong verbal and written communication skills.
• Strong organizational skills, and attention to detail.
• Ability to function well in a high-paced environment.
• Proficient with Microsoft Office Suite or related software.

Nice To Haves

• A working understanding of global GxP regulations, along with familiarity in GMP SOPs and quality system processes, is preferred.

Responsibilities

• Responsible for uploading documentation into our EDM system.
• Responsible for overall documentation issuance (such as, but not limited to procedures, test methods, specifications validations, and study reports); data entry and archival processes to support documentation and training activities.
• Collaborates with cross-functional departments, to ensure timely implementation of document change requests.
• Ensures accuracy by reviewing documents for completeness, proper authorization, and impact to other quality systems.
• Support audits (internal, external)
• Update and create training curriculum revisions as needed
• Perform other duties and special projects as assigned to support the doc control team.

Benefits

• short-term incentive bonus opportunity
• eligibility to participate in our equity-based long-term incentive program
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees