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Specialist I, QA Raw Material Release

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 Quality Specialist in the Quality Assurance department is responsible for the release of bulk materials, raw materials and components for use in Manufacturing and QC Labs.

II. ESSENTIAL FUNCTIONS

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

 

  • Review, evaluate and approve test results to disposition materials for use in manufacturing or testing.
  • Work with Quality Control, Materials Management, and other departments on creating specifications.
  • Revise Quality Assurance SOPs as required to ensure procedures are compliant with CGMP.
  • Critically review various types of documentation to ensure completeness, accuracy, and compliance, including: SOP revisions, protocols, data sets, material specifications, work orders, calibration records, and validation reports
  • Support deviation investigations, CAPA’s & Change controls.
  • Identify and implement process and system improvements.
  • Support site inspections from regulatory agencies including escorting inspectors, speaking as Quality Assurance subject matter expert, and preparing documentation for auditor review. 
  • Additional Quality Assurance activities as required.
  • Requires vaccination against different viruses including Vaccinia virus

 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education:      BA/BS (preferably in an Applied Science) or equivalent work experience.

Experience:     Minimum 5 years of experience working in a CGMP manufacturer, Aseptic   Manufacturing, Quality Control and previous Quality Assurance experience preferred.

Skills:             Knowledge of MS Word, Excel and PowerPoint.

Candidate must exhibit strong interpersonal and communication skills. Strong oral and written communication skills.

Ability to work independently and in a team setting with minimal supervision.

Ability to make sound decisions regarding compliance-related issues with minimal supervision.

Strong leadership, high level of personal/departmental accountability and responsibility and ability to Act as an approved delegate of the Quality Assurance Management Team (Supervisor/Manager).

Requires 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.

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