Document Coordinator II

Description

ESSENTIAL FUNCTIONS :

• Manages and controls records maintained by QA Documentation Control area throughout their lifecycle (creating, approval, storage, retrieval, retention, disposition, and destruction / transfer) in accordance with regulations and industry standards. Processing documents will account for up to 90% of daily tasks.
• Prints, issues, and reconciles labels and batch records for production of intermediate and finished manufactured products at the St. Louis Plant.
• Activities may include supporting other internal Par Health manufacturing sites.
• Provides input and revises procedures related to Document Control to standardize methods, to ensure compliance, to implement improvements, and to reduce errors.
• May prepare monthly metric reports and analyze data for trends.
• Assists users in submitting and locating records (paper or electronic) as needed, in record retrieval and submission.
• Enters data and ensures the accuracy of Iron Mountain database metadata.
• Assists in maintaining department standards for electronic documents and electronic signatures including document imaging and electronic storage requirements.
• Actively seeks, communicates, and assists in implementing quality process improvements as well as cost effective and safety improvements in the department.
• Assists in investigation of unexpected events and quality issues within the department and helps identify preventive and corrective actions.
• Participates in cGMP walkthroughs, internal and external (customer and / or regulatory agency) audits as instructed.
• Maintains knowledge of cGMPs, Regulatory and Quality Assurance requirements and guidelines.
• May serve as a cross-functional team member to resolve compliance and conformance issues at the site.
• Provides training to new or existing employees for the document management system.
• Conducts all activities in a safe manner and is an active participant in safety investigations.

DEPARTMENT SPECIFIC / NON-ESSENTIAL FUNCTIONS :

MINIMUM REQUIREMENTS :

High School Diploma or GED equivalent is required.

ORGANIZATIONAL RELATIONSHIP / SCOPE :

This individual reports to the Mgr Quality Training and interacts with internal customers (Manufacturing) on a daily basis.

COMPETENCIES :

Action Oriented, Customer Focus, Functional / Technical Skills, Problem Solving and Technical Learning

WORKING CONDITIONS :

DISCLAIMER : EEO Statement :

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.