Analyst III, Quality Assurance

Location
Rockville, MD, US
Posted
Apr 10, 2021
Ref
722218500
Hotbed
BioCapital
Required Education
Other
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 QA Analyst III is responsible for assisting and supporting preparation, testing, and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. They identify risk and evaluate deficiencies while working with internal departments to appropriately remedy them. They facilitate internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.

II. ESSENTIAL FUNCTIONS

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

  • Critically review and approve various types of documentation to ensure completeness, accuracy, and compliance including, but not limited to, manufacturing records and Quality Control laboratory data for batch and material releases, specifications, SOPs, validation protocols and summary reports, master plans, deviation investigations, CAPAs, and change controls.
  • Exercises good judgment within defined procedures to determine appropriate action for resolution of manufacturing or laboratory issues
  • Serves in a decision-making capacity on major document changes, deviations, corrective and preventive actions, change control, and other projects
  • Performs in-process audits of manufacturing facilities and processes, including aseptic processes and behavior.
  • Reviews routine work orders, return-to services, and other documents to ensure that equipment and utilities are fit for use.
  • Network with senior internal and external personnel in own area of expertise.
  • Communicates effectively with management project status, issues, and mitigations.
  • Assumes responsibilities for assigned tasks including a subset of the activities listed herein.
  • Participates in batch release and all quality systems associated with batch release:
    • Review of manufacturing and testing records to ensure compliance to site procedures, regulatory requirements, and product license requirements.
    • Review deviation investigations, including root cause analysis.
    • Supports the development and execution of CAPA plans to address identified deviation root causes or compliance/quality gaps.
    • Coordinates and supports the development and execution of change control plans to ensure compliant implementation of product and/or process changes.


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
  • BA/BS (preferably in an Applied Science) or equivalent work experience
  • 3-5 years of CGMP experience
  • Prior experience with US and EU pharmaceutical regulations, ISO standards
  • Knowledge and application of CGMP principles and working in FDA-regulated environment.
  • C ritical analytical skills and strong verbal and communication skills
  • Ability to work under pressure and analyze processes within scheduled timeframes
  • Ability to work independently and in a team setting with minimal supervision.
  • Ability to make sound decisions regarding compliance-related issues with minimal supervision. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.


* 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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