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Quality Assurance (QA) Validation Specialist

Company: CAMRIS International
Location: Silver Spring
Posted on: May 3, 2021

Job Description:

CAMRIS International, LLC is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research. 

 

We are seeking a Quality Assurance Validation Specialist I/II to support the Pilot Bio-Production Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.


  • Accountable and responsible for the lifecycle management of instrument, equipment and system validation at the Walter Reed Pilot Bioproduction Facility.
  • Assists the QA Manager in developing, maintaining, and administering the PBF Validation Policy, Validation Master Plan(s) and all SOPs related to the site's validation.
  • Assist the QA Manager in projects associated with equipment lifecycle, validation, and calibration responsibilities.
  • Authors validation protocols, and reports; reviews and approves protocols and reports developed by validation service providers and equipment vendors.
  • Oversees validation activities performed by contract service providers.
  • Assist with writing, reviewing, and executing User Requirements Specifications for instruments, equipment, and systems.
  • Works with equipment owners to define and execute the activities required to bring equipment into GMP service (risk assessment, validation, calibration, SOP generation, preventive maintenance determinations/scheduling, etc.).
  • Coordinates with Quality Control, Operations, Biologics Process Development, and Facilities to investigate and resolve deviations through determining root cause, product impact, and appropriate corrective and preventive actions related to equipment or validated process parameters.
  • Supports audits, assists in providing responses to audit observations, and manages audit related CAPA commitments for equipment and systems, as required.
  • Maintains Equipment History Files and logs.
  • Compiles PBF departmental metrics related to equipment and validation on a monthly basis or when necessary.
  • Leads PBF Quality Assurance at PBF Quarterly Quality meetings and other ad-hoc meetings when directed.
  • Escorts service vendors when necessary.
  • Performs other duties as assigned.

  • Bachelor’s degree in engineering or sciences degree with additional industry experience.  Masters in Engineering or PhD in related science preferred.
  • Two-four years of relevant cGxP experience in a biopharmaceutical or life sciences development or manufacturing environment in calibration, validation, operations, and engineering.
  • Desirable cGxP validation experience, including lab instrumentation, process equipment, and Quality Control instrumentation.
  • Preferred experience in Computer Systems Validation (CSV) experience including laboratory computer systems, laboratory information management systems (LIMS), SCADA/monitoring systems and building management systems.
  • Ability to interpret engineering drawings and design documentation.
  • Familiarity with related fields, such as microbial physiology, general microbiology, microbial fermentation, mammalian cell culture, physical chemistry, and biochemistry.
  • Experience using DocuSign for workflow management and implementing/using enterprise content management platforms preferred.
  • Proficient at Microsoft office, especially MS Excel and Word.
  • Experience in the compilation of upstream electronic and offline data.
  • Comfortable and effective presentation of process data to internal and external peers, customers, and stakeholders.

CAMRIS International, LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Keywords: CAMRIS International, Silver Spring , Quality Assurance (QA) Validation Specialist, Other , Silver Spring, Maryland

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