Laboratory Quality Systems Specialist

General Summary

Responsible for monitoring the laboratory processes to ensure overall compliance with CSL Plasma Services (CSLPS) operating procedures as well as any other applicable State, Federal or international regulatory requirements. Responsible for reporting compliance status to Operational and Quality Management. Participates with Laboratory personnel in the development and implementation of continuous improvement plans.

Responsibilities

• Responsible for Quality Assurance oversight of laboratory operations to ensure compliance with State, Federal and International regulatory requirements including CLIA, FDA and GHA and customer specifications.
• Examines Quality Records to ensure thoroughness, accuracy and timeliness of required information. Reports non-conformances to management for appropriate follow-up.
• Maintains system to document, track and trend non-conformances and/or exceptions to procedures.
• Reviews proposed corrective and preventative actions for appropriateness. Monitors timeliness of corrective action implementation to ensure compliance with procedural guidelines.
• Conducts follow-up inspections to verify efficacy of corrective action plans.
• Maintains and utilizes Access and Excel databases in order to develop and deliver periodic reports and trend analyses to Operations and Quality Management personnel.
• Suggests and facilitates implementation of process changes designed to correct problems noted during trend analyses.
• Provides QA support for Anti-D Lab and IRBC Manufacturing program. Performs batch review and release.
• Conducts periodic process assessments to ensure accuracy and relevance of CSLPS written procedures. Recommends and implements changes to procedures based on observations to ensure compliance with regulatory guidelines.
• Reviews data and reports submitted to support validations. Assures both follow proper cGMPs and SOPs. Maintains laboratory validations and an index of validations stored on site.
• Provides QA review and release for incoming reagents.
• Reviews personnel competency assessments to ensure compliance with CSL procedures, SOPs, CLIA and other applicable requirements.
• Monitors complaints and assures their timely investigation, root cause analysis, resolution and closure. Reports trends to Operations and Quality Management.
• Other job-related duties as assigned.

Job Specifications

Education: Bachelor's Degree in a scientific field.

Experience: Five or more years' experience in a laboratory setting, including one-year experience in a regulated environment and one-year internal quality auditing experience. Additional experience may substitute for the Bachelor's Degree.