Analyst III, Document Control

Location
Rockville, MD, US
Posted
Sep 23, 2020
Ref
677794200
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I. JOB SUMMARY

The role is responsible for the administration and maintenance of controlled documents, records, and the document control system in accordance with GMP and company requirements. Timely completion of department tasks, and training new employees.

Provide support during regulatory inspections.

II. ESSENTIAL FUNCTIONS

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

Document Control Support
  • Provide support for internal and external 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.
  • Execute user testing for supported computer system program changes.


Quality System Support
  • Author and execute tasks for document revisions, non-conformances, CAPAs, and change controls related to Document Control quality system performance.
  • 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.


Regulatory Inspection
  • Provide support and technical knowledge during regulatory, internal and client inspections of Emergent quality systems.
  • Participate on response teams to address observations and recommendations made during inspections.


III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education: BS degree or equivalent level of skill and experience.

Experience:
  • 3-6 years related experience.
  • Experience with electronic document management, non-conformance, CAPA, and change control systems.
  • Minimum of 3 year in an FDA regulated industry.
  • Strong computer skills with the Microsoft Office product line.
  • Moderate understanding of regulations governing document control and record management.
  • Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations.
  • Ability to work individually and in a team environment with minimal supervision.

Skills: Knowledge of MS Word, Excel and PowerPoint.

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

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

Travel:

Minimal travel to other sites.

Other Requirements:

R equires vaccination against different viruses including Vaccinia virus.

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 Privacy Policy .

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.