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QA Specialist (GCP/CAPA)

  • Type Contract
  • Salary US$80.00 - US$95. per hour + competitive
  • Location District of Columbia, USA
  • Sectors Pharma & Biotech

Responsibilities

  • Quality Assurance and Process Improvement

◦Demonstrate Quality training and ensure personnel understand and adhere to Quality requirements and SOPs

◦Lead process improvement initiatives

◦Lab Audits in compliance with GCP & SOP requirements

◦Experience in the document development process

◦Supplier qualification

◦Host site visits/inspections/audits as requested

◦Log and manage deviations, participate in the CAPA process, perform effectiveness checks

◦Participate in record review, including computer system validation

◾Serve as point of contact, responsible for managing, scheduling, and documenting activities, site audits, and reports

◾Perform administrative updates to protocols in conjunction with Principal Investigators

◾Assists with maintenance of the occupational health program

◾Serve as a resource to departments to maintain a safe working environment - identifying hazards, risks, and appropriate mitigation

◾Identify processes to meet Federal, state and local regulatory requirements, such as EPA, OSHA, MDE, including reporting in accordance with timelines

Education

  • BS/BA degree.
  • Certification preferred, not required
  • Demonstrated comprehensive knowledge of and experience in quality assurance and process improvement.
  • Experience in regulatory and compliance aspects of clinical laboratory and/or in vivo

Sthree US is acting as an Employment Business in relation to this vacancy.