Analyst II, Document Control

Job summary

The role involves administering and maintaining controlled documents, records, and the document control system while supporting regulatory inspections. Responsibilities also include troubleshooting technical issues, conducting audits, and providing training on operational procedures.

Job details

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions tocommunities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.Job Summary The role is responsible for the administration and maintenance of the company’s controlled documents, records, and the document control system in accordance with company requirements. Monitoring completion of department tasks, training new employees and providing support during regulatory inspections. Responsibilities Document Control Support Troubleshoot and provide support for internal customers with technical questions related to Document Control quality systems. Support completion of department operational tasks related to record and document issuance, processing, reconciliation and archival. Conduct routine audits of department operational processes and provide recommendations for improvement. Conduct new department employee training on operational procedures and provide input on new and revised training content. Quality System Support Compile and report performance metrics for Document Control quality systems and provide recommendations to improve performance. Administer and maintain the company’s Electronic Document Management System (management and maintenance of system information). Creation of standardized procedures and work instructions for Document Control. Creation and maintenance of training material for company’s Electronic Document Management System. Represent the Document Control department on site and global projects. Oversee assignment and tracking of internal customer requests, including responsibility for service requests from other departments in the organization. Identify opportunities for improvement within scope of work. Provide support during regulatory and internal inspections of Emergent quality systems. Assists with the management of third party audits. Other duties as assigned. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Education, Experience & Skills Minimum of grade 12 education required. Bachelor degree preferred. 2-4 years related experience. Experience in an FDA regulated industry. Experience with electronic document management systems. Strong computer skills with the Microsoft Office product line. Basic understanding of regulations governing document control and records management. The position requires excellent communication and organizational skills. The position must have strong interpersonal skills and have good attention to detail. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

What you’ll do

The role involves administering and maintaining controlled documents, records, and the document control system while supporting regulatory inspections. Responsibilities also include troubleshooting technical issues, conducting audits, and providing training on operational procedures.

Requirements

Candidates must have a minimum of a grade 12 education, with a bachelor's degree preferred. Applicants should possess 2-4 years of related experience, preferably within an FDA-regulated industry, and proficiency with electronic document management systems.

Benefits

• Competitive salaries
• Flexible work arrangements
• Extensive benefits package

Listed skills

• Training · Preferred
• interpersonal skills · Preferred
• Attention to detail · Preferred
• Microsoft Office · Preferred
• Communication Skills · Preferred
• Technical Support · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Document control
• Records management
• Quality systems
• Electronic document management systems
• Regulatory inspections
• Auditing
• Performance metrics
• Technical support
• Training
• Microsoft office
• Communication skills
• Organizational skills
• Interpersonal skills
• Attention to detail
• Business Metrics
• Organizational Skills
• Document Control
• Quality Management Systems
• Reconciliation
• Management
• Communication
• Computer Literacy
• Training And Development
• Document Management Systems
• Interpersonal Communications
• Microsoft Office
• Performance Metric
• Product Lining
• Troubleshooting (Problem Solving)
• Detail Oriented

Job areas

• Healthcare
• Administrative
• Science & Research
• Document Control Analyst
• Document Control / Management Specialist
• Filing and Copying Clerks
• Document Management Specialists
• Computer Occupations, All Other

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