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Specialist II, QA

Emergent Biosolutions - Rockville, MD

Posted 14 days ago

3 people have applied

Job Description

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 Quality Assurance, Specialist II will provide QA oversight and support of quality systems in support of commercial product manufacturing at the site and managed activities for one or more quality system or cross-functional project.

The Quality Assurance, Specialist II will provide a broad scope of technical knowledge to analyze risk, troubleshoot highly complex issues, support quality systems, and plant compliance.

This role will also apply expertise and regulatory knowledge to support change and risk management, as well as lead/assist in hosting audits/inspections.




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

Quality System Support

    Serve as process owner for:
    • Change Controls
    • CAPAs
    • Data Integrity / Data Governance
    • Risk Management
    • Act as process subject matter expert with detailed knowledge of process history, compliance, operations, changes, and deviating events
    • Monitor performance metrics, including identification of trends that require preventive action and cross-functional collaboration to determine the root cause of process performance issues, and taking the necessary action to improve performance
    • Present objective data regarding process performance to Functional Area and Senior Management
    • Maintain up-to-date knowledge of industry and regulatory trends to ensure system remains compliant with stated expectations and best practices
  • Process access requests, perform user analysis, and make recommendations for relevant computer systems for supported quality systems
  • Develop, schedule, and conduct site training for supported quality systems, assess effectiveness of training following completion
  • Represent the Quality Systems department in a review and decision-making capacity on site projects
  • Coordinate work across systems, functions, and sites to harmonize workflow, clearly identify responsibilities, and optimise cross-functional team member participation
  • Network with counterparts at other sites to leverage and implement best practices
  • Coordinate/lead cross-functional teams in process mapping and other exercises designed to facilitate process and systemunderstanding
  • Assist in the development of procedures and other documents to accurately reflect work practices, including application of documentation format, structure, and hierarchy standards
  • Actively apply quality tools and training to ensure the best possible outcome of quality improvement efforts

Continuous Improvement

  • Identify opportunities for improvement within scope of work
  • Maintain documentation of quality improvement efforts that is suitable for presentation to site leadership and during audits & regulatory inspections
  • Coordinate and lead department improvement activities (i.e., 6S,
    PDSA cycles)
  • Develop training materials and educate department personnel on lean concepts

Inspections / Audits

  • Lead logistical support and technical knowledge during internal audits and external inspections of Emergent quality systems, including interacting directly with audit and regulatory personnel to discuss areas of expertise
  • Lead on response teams to address observations and recommendations made during internal audits and inspections


May require vaccination against various viral products, including the Vacciniavirus.

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 restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.




  • Bachelor's degree, preferably in an applied science
  • American Society for Quality (ASQ) certification (preferred)


  • Minimum of 5 years relatedexperience
  • Minimum of 5 years in an FDA regulated industry


  • High understanding of deviation investigation, root cause analysis, CAPA, and changecontrolsystems
  • Expert understanding of regulations governing supported processes and systems


  • Strong computer skills with the Microsoft Office product line
  • Strong leadership skills; high level of personal/departmental accountability and responsibility


  • 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
  • Ability to make sound decisions regarding quality and compliance related issues
  • Ability to lead small groups of employees to accomplish common goals

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.


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.


    Stand shoulder to shoulder no matterwhat
    • 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.

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