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Supervisor, Document Control

Location: 

Rockville, MD, US, 20850


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 Supervisor, QA Document Control is responsible for supervising the Document Control staff.  Ensures that the document control system complies with CGMP and company requirements.  Timely completion of department tasks, and training new employees.  Provides support during internal/external audits and regulatory inspections.

 

II. ESSENTIAL FUNCTIONS

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

 

  • Supervises daily operations he of the Document Control staff.
  • Manages the development needs of Document Control staff to support the evolving Quality Systems at the site.
  • Provides monthly reports on Departmental metrics, highlighting areas of concern to senior management.
  • Formats documents to meet the requirement of Veeva.
  • Trains employees on using Veeva.
  • Manages the electronic document management system and lead process improvement by developing and implementing plans to evolve internal systems for greater efficiency and quality.
  • Manages the document management system to issue, retrieve, and archive controlled documents as needed by the site.
  • Ensures Emergent documentation retention requirements are applied to GXP documents.
  • Authors and executes tasks for document revisions, non-conformances, CAPAs, and change controls related to Document Control quality system performance.
  • Provides oversight for training of personnel relating to execution and interactions in the document management system.
  • Provides support during internal/external audits and regulatory inspections.
  • Teams up with Corporate Document Control to:
    • Issue and maintain corporate documents, ensuring only current, released documents are available.
    • Ensure documentation practices within EBSI are consistent and complementary.
  • Requires vaccination against different viruses including Vaccinia virus.

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.

 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

  • BS degree, preferably in a life science related discipline, or equivalent work experience.
  • Minimum of 4-6 years in an FDA regulated industry or Quality Assurance with at least 1-2 years of supervisory experience required.
  • Must possess strong computer skills in the Microsoft Office product line.
  • Working knowledge of SAP is preferred.
  • Working knowledge of Veeva preferred.
  • Must be able to effectively communicate (orally and written) with all levels of personnel.

 

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.

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

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


Nearest Major Market: Washington DC