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Analyst III, Global Quality Systems

Location: 

Gaithersburg, MD, US, 20879


 

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.

The Emergent BioSolutions Global Quality Systems Analyst III – Document Control will support the execution and deliverables associated with the harmonization of our Global Quality Management System across the enterprise.  More specifically, this Analyst III will take on a lead role in maintaining controlled documents and records in accordance with requirements and partnering with Global Process Owners to ensure the regulations and standards are reflected within the documents.  
This position will play a key role in the development and maintenance of the data hierarchy and approval matrix, partnering with the Quality IT in the development of the solution.
This role will lead projects and collaborate with other team members in the development of tools, methods, and processes for managing a globally harmonized Quality Management System.   

 

 

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

Quality Systems 

  • Provide document control support for Global Quality, Corporate, and 400P including controlled documents and records, manual records, archival, user access, lab notebooks, logs, issuance and reconciliation, signature registration, etc.
  • Ensure document changes are complete, accurate, and compliant.
  • Collaborate with Global Process Owners to release and maintain global documents in a timely manner.
  • Own the translation process for all controlled documents within the scope of this position.
  • Partner with QA IT to develop the requirements and implement IT solution for the data hierarchy and approval matrix.
  • Partner with team members to ensure consistent management of documents for Emergent.
  • Provide document control reports to Global Process Owners for use in document assessments for the globally harmonized Quality Management System.
  • Develop and maintain tools for Global Harmonization such as Document Templates, Style Guide, Global Glossary, etc.
  • Learn how to configure the Document Management System to enable timely updates within our control.
  • May perform site process assessment to ensure effectiveness of global deployments 
  • Lead and manage Global projects, CAPA’s and Deviations as needed 
  • Lead or participate in cross-functional teams to address global issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product 
  • Perform periodic review of document retention periods and coordinate transfer of records to off-site storage, as needed.
  • Track and trend various components of document control process such as controlled document deliverables, laboratory notebook issuance, archival data, and training plans.

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

  • Bachelor’s Degree preferred or applicable relevant work experience is acceptable, in place of degree
  • A minimum of five (5) years' experience in Good Manufacturing Practices, Good Laboratory Practices and/or Good Clinical Practice environment in a Document Control or Quality related role
  • Knowledge and application of GMP principles, and working in an FDA regulated environment
  • Strong communication skills: oral/written and listening
  • Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
  • Interpersonal skills: team building, consensus building, conflict resolution
  • Proven attention to detail and ability to work independently within scheduled timeframes
  • Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.  Previous Document Management System experience a plus.
  • Good presentation skills, including written and verbal communication skills
     

 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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