Analyst II, Document Control

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Emergent BioSolutions is committed to assisting employees achieve their professional goals. Internal job postings are one of the tools available to employees at Emergent BioSolutions to assist in their career management. This enables current employees who have remained in their current position for a minimum of one year to apply for an open position.

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 (key responsibilities only. This should not be an all encompassing list)

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, 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 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.
• Lead quality events and investigations related to Document Control.
• 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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder no matter what
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • Every person at Emergent is engaged and accountable for delivering on our commitments.
• Break through thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.