Document Coordinator II

Document Coordinator II

At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purposeprioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.

The Document Coordinator II manages documents maintained by QA Document Control (QAD). This includes controlled documents in Metric Stream and product and safety labels in CodeSoft. QAD is responsible for these documents throughout their lifecycle in accordance with Company and regulatory guidelines and expectations. QAD performs system and records management functions, seeking to improve existing operations within the documentation systems. QAD prints, issues, and reconciles labels and batch records for production of intermediate and finished manufactured products at the St. Louis Plant.

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 :

Preferred Skills / Qualifications :

Other Skills :

Organizational Relationship / Scope :

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

Competencies :

Working Conditions :

Disclaimer :

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

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.