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Quality Assurance Specialist

Department of Regulatory Affairs & Quality Assurance

Position Description:
This position provides immediate support to the Regulatory Affairs/Quality Assurance (RAQA) team to help ensure implementation, maintenance, and improvement of the quality management system. Under the supervision of the RAQA Director, you will:

  • Write and review Standard Operating Procedures (SOPs)
  • Support ongoing process improvement endeavors
  • Maintain and ensure applicable regulatory and internal QMS compliance for staff training/personnel files, master schedule, deviation trending/tracking, etc.
  • Perform in-phase inspections for clinical/nonclinical laboratory studies or tests, writing inspection reports, following up on observations/CAPAs
  • Provide QA support for internal and sponsored projects including reviewing protocols and reports
  • Work collaboratively with staff responding to and resolving deviations and incidents
  • Follow through on corrective and preventative actions from deviations and audit observations
  • Maintain databases for investigations, audit observations and CAPA
  • Assist clients and regulatory agencies with audits, vendor questionnaires, addressing audit reports and following up on observations/CAPA
Position Qualifications:
  • Bachelor’s or Master’s degree in the Life Science field
  • RQAP and/or ASQ certification preferred
  • Minimum two years of related experience in Quality Assurance
  • Prior audit and inspection experience required
  • In depth experience in laboratory regulatory requirements and industry standards required
  • Knowledge of ICH E6 (R2) GCP Clinical Research Trials design and QAU function preferred
  • Ability to prioritize and perform work while adhering to deadlines
  • Strong interpersonal skills necessary to work with multifunctional teams
  • Possess excellent verbal and written communication skills
  • Proven ability to work well in a team environment to consistently meet deadlines
  • Must be proficient in use of Microsoft Office particularly Excel spreadsheets

Interested applicants should email a resume with cover letter to:

CTL is fully committed to Equal Employment Opportunity without regard to race, sex, color, religion, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status.