Document Coordinator II

Why Us?

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 purpose—prioritizing 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 Code Soft. 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.

• 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.

• Orders office supplies and other administrative tasks as assigned.

Education:

High School Diploma or GED equivalent is required.

Experience:

• 1 to 3 years related experience is required
• Experience in cGMP pharmaceutical business

Preferred Skills/

Qualifications:

• Experience in a lead role for maintaining a document management system or in a lead role for issuance of batch records and labeling for a manufacturing environment.
• Preferred knowledge of the inventory management software (BPCS) and the document management system (Metric Stream)
• Familiarity with Good Documentation Practice and Record/Information Management methodology.
• Superior computer skills including knowledge of document imaging and indexing systems, database system development and implementation
• Experience in training is preferred.

Other

Skills:

• Document Management (Metric Stream; Documentum), Code Soft or equivalent label design software
• Word (Advanced level), Access, Excel, PowerPoint,
• Excellent written and oral communication skills.
• Excellent organization skills and ability to prioritize tasks
• Ability to operate in a fast-paced…