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Analyst I, QA

Company: Emergent BioSolutions, Inc.
Location: Baltimore
Posted on: March 28, 2020

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. I: Job Summary The Quality Analyst I is an entry-level role for support of quality systems and plant compliance. This role will gain experience in the oversight to projects to maintain internal/external customer expectations. They exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. They serve as a resource of technical knowledge for established processes. The candidate will apply regulatory knowledge to support change and risk management, including application of scientific and technical innovation. They identify risk and evaluate mitigation strategies to address such risk. They identify opportunities for improvement at the site using Six Sigma methodologies. II: Essential Functions General

  • Critically reviews various types of documentation to ensure completeness, accuracy, and compliance including but not limited to manufacturing records for batch and material release, specifications, validation protocols and summary reports, regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, Request For Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls
  • Communicates effectively with management project status, issues, and mitigations
  • Assumes responsibilities for assigned tasks including a subset of the activities listed herein Product & Material Release
    • Independently review and perform disposition of raw materials, components, bulk drug substance, and final drug substance
    • Release raw materials using SAP system
    • Liaise with contract manufacturers responsible for filling, inspection, labeling, and packaging of product by providing Quality oversight for deviations, change controls, and other quality systems that may impact EMOB's products
    • Assist with oversight and support of reference materials and retention programs QA on the Floor
      • Support/execute QA on the Floor program
      • Support/execute revision and creation of Standard Operating Procedures in document management system
      • Support/review and approve executed Batch Record review
      • Support Batch/Cell Bank disposition
      • Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement and QA
      • Support QA oversite for incoming commercial and clinical projects
      • Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues.
      • Initiate Quality Notifications (Deviations, CAPA's and Change Controls)
        • Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues
        • Receive assignments in the form of objectives to help achieve department goals
        • Participate in company sponsored training
          • Support regulatory and client audits
          • Provide Quality input/support to investigations, CAPAs and changes
          • Support site inspection readiness strategy and activities The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. III: Education, Experience & Skills
            • Bachelor's Degree in Scientific, Engineering or related fields
            • A minimum of 0-2 years of CGMP Quality experience
            • Ability to work independently with minimal supervision
            • Strong Commercial manufacturing experience (Large Molecules)
            • Prior experience with US, EU and Canadian pharmaceutical regulations, ISO standards
            • 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
            • Critical analytical skills, strong verbal and communication skills
            • Ability to work under pressure and analyze processes within scheduled timeframes
            • Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, and Visio.
            • Ability to travel (10%) IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS 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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.

Keywords: Emergent BioSolutions, Inc., Baltimore , Analyst I, QA, Professions , Baltimore, Maryland

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