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
Click
here to apply!
|