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Analyst II, Document Control

Company: Emergent Biosolutions
Location: Lansing
Posted on: January 21, 2023

Job Description:





We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
JOB SUMMARY

Ensures documents meet established formatting standards and manages implementation activities in the Document Management System. Completes record activities including issuing, reconciling, scanning, and archiving. Provides oversight and support of document and records management activities. Conducts process and personnel training. Provides support during internal audits and regulatory inspections.



ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.



Document Control Support

* Ensure documents meet established formatting standards

* Manage implementation activities of documents, including lifecycle states in the Document Management System, user notifications, and issuance & reconciliation of controlled copies

* Complete record activities including issuing, reconciling, scanning, and archiving

* Troubleshoot and provide support for internal customers with technical questions related to Document Control processes and IT applications

* Participate in routine audits of Document Control processes and provide recommendations for improvement

* Represent the Document Control department on site projects

* Process access requests for Document Control IT applications

* Develop and conduct new Document Control employee training on operational procedures

* Conduct entry-level site training for Document Control processes and provide input on new and revised training content

Quality System Support

* Author and execute tasks for document revisions, deviation investigations, CAPAs, and change controls related to Document Control processes

* Compile and report performance metrics and data supporting Document Control processes

Continuous Improvement

* Identify opportunities for improvement within scope of work

* Coordinate and lead department 6S activities

* Educate department personnel on lean concepts

Regulatory Inspections

* Provide logistical support and technical knowledge during internal audits and regulatory inspections of Emergent quality systems

* Participate on response teams to address observations and recommendations made during internal audits and inspections



The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS



Education

* High school diploma

Experience

* 2-4 years working with an electronic Document Management System

* 2-4 years working within a regulated industry (at least 1 year of working in an FDA regulated industry preferred)

Knowledge

* Moderate understanding of regulations governing document and records management

* Basic understanding of deviation investigation, root cause analysis, CAPA, and change control systems

Skills

* Strong computer skills with the Microsoft Office product line

Abilities

* Ability to work individually and in a team environment with minimal supervision

* Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations


Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.



Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.



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 .



Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Keywords: Emergent Biosolutions, Lansing , Analyst II, Document Control, Professions , Lansing, Michigan

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