Document Coordinator II

At Par Health, we believe great healthcare is built on getting the essentials right. Were 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 isnt just our tagline, its the higher standard we live by every day.

• Job Description Summary
• 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.
• Job 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
• Orders office supplies and other administrative tasks as assigned.
• MINIMUM REQUIREMENTS
• 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 (MetricStream; Documentum), CodeSoft 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 environment
• Ability to work independently as well as in a team environment
• Strong attention to detail
• 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 :
• 95 % of office environment which includes sitting for long periods of time and computer use.
• 5 % of manufacturing environment exposure including temperature, noise, chemical or potent compound exposure.
• 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.Come join us! At Par Health, we believe great healthcare is built on getting the essentials right.Were 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
• isnt just our tagline, its the higher standard we live by every day.

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