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

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.