Document Control Coordinator

21st Century HealthCare, Inc. is a leading manufacturer of dietary supplements, based in Tempe, Arizona. The company has been making quality nutritional products for over 30 years. The company maintains high standards for product purity and quality. 21st Century offers a competitive benefits program promoting health and wellness.

Benefits Offered: Medical, Dental, Vision, HSA, 401k, Employee Discount, Vacation Pay, Sick Pay, Holiday Pay, and more!

Job Summary: Control and maintain all relevant quality system documentation for dietary supplement and food manufacturing environment that comply with FDA regulations, including, SOPs, logs, forms, manufacturing records, work instructions, good documentation practices and adequacy of reference procedures and part numbers.

Reports To:

• Director of Quality Systems Management

Essential Functions:

• SOP’s/Training
• Mange the SOP system through creation and development of SOPs, revision management, and routine reviews.
• Assist subject matter experts with the development of systems, related processes, and work instructions.
• Provide input and feedback during process development to ensure clarity, ease of understanding, and compliance with all company policies and local, state, and federal regulations.
• Coordinate all SOPs through the Training Management System to ensure appropriate all SOPs are trained on appropriately, through qualified trainers, to employees or stakeholders where training is required for the fulfillment of job functions
• Manage the approved trainer process.
• Oversee the training management system to ensure training is provided in a timely manner through the employee on-boarding and/or document revision processes.
• Coordinate with department managers regarding the completion of all required training, document changes, new documents, and training gap analyses.
• Provide general training and oversight for all document control aspects regarding document creation, document retention, and document/sample destruction.
• Assist in customer, certification, and regulatory audits.
• Assist with conducting quality audits, identifying, documenting, and providing solutions for non-conformances, corrective actions, and preventive actions.
• Compile and analyze process metrics for Key Performance Indicators (KPIs) through the creation and maintenance of logs/registers, spreadsheets, databases, or other IT applications
• Performs additional duties as assigned.

Education and Experience:

• Accuracy with arithmetic, subtraction, multiplication, division, decimals, percentages, fractions, and algebra.
• Must be able to communicate complex concepts in English, verbally and in writing.
• Must be able to use Microsoft Office, operate inventory software, time keeping or other business-related software.
• Computer Skills – Must be proficient with Microsoft Office, Document Management software, other business-related software, and data entry including filing/storage.