Documentation Management System Processor

Use Your Power for Purpose

Every day, our unwavering commitment to quality and the delivery of safe, effective products to patients guides everything we do. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the customer first. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution has a direct impact on patients. As a member of the Global Supply division, you will play a crucial role in improving patients' lives while working r dedication and hard work ensure that customers and patients receive the medicines they need when they need them.

What You Will Achieve

In this role, you will:

• Prepare and review essential documentation, including GMP, GLP, and GCP manuals.
• Create procedure manuals, quality control manuals, engineering documents, manufacturing instructions, and change authorizations in compliance with company policies and regulations.
• Implement documentation systems, propose change control processes, and coordinate the review of procedures and forms.
• Provide input on quality control procedures and R&D documentation.
• Enter and maintain critical information in change control and document control databases such as QTS, PDocs, and GDMS.
• Compile and review data from various business areas and systems, using software to generate reports, statistics, timelines, tables, graphs, correspondence, and presentations.
• Maintain metrics for key quality performance indicators at the site.
• Perform routine audits, monitor files, and create and review data-rich documents to support investigations and validation activities.
• Ensure compliance with SOPs for Change Control and Documentation, utilizing systems like rDocs, HPI, AS400, and SAP for cross-references and control implementation of product documentation.
• Manage personal time, professional development, and workflow, assist less-experienced colleagues, track resources, provide detailed reports, and work independently under general supervision, completing tasks and sharing knowledge within the work group.

Here Is What You Need (Minimum Requirements)

• High School Diploma or GED with at least 4 years of experience
• Proficient computer entry and database management skills
• Demonstrated hands-on experience with Microsoft Products such as Word, Excel, and Power Point
• Excellent written and verbal communication skills
• Strong attention to detail and accuracy
• Ability to manage multiple tasks and prioritize effectively
• Familiarity with documentation systems and quality control procedures

Bonus Points If You Have (Preferred Requirements)

• Strong reading comprehension and proofreading skills
• Experience with change control and document control databases such as QTS, PDocs, and GDMS
• Knowledge of Good Manufacturing Practices, Good Laboratory Practices (GLP), and Good Clinical Practices (GCP)
• Ability to adapt to changing priorities and work under pressure
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to read and understand required documentation. Satisfactory performance and attendance are required.
• Subject to frequent interruptions of normal routine activities.
• Considerable mental/visual concentration, coordinating manual dexterity with mental/visual attention.
• Ability to stand for 1 hour a time, sit for 2 to 3 hours a time. Require working in an office setting where sitting and computer usage would be typical.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Work Location Assignment:
  On Premise
• Requires regular onsite attendance
• Must have the ability to work effectively under strict deadlines
• Must be able and willing to work beyond office hours which may include weekends and holidays

The salary for this position ranges from $23.40 to $39.01 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on…