Specialist I, QA Raw Material Release

Location
Rockville, MD, US
Posted
Jun 10, 2021
Ref
731375700
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 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.
  • R equires 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).

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.

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