Laboratory Quality Systems Specialist

GENERAL SUMMARY
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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.

REPORTING RELATIONSHIP
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Reports To: Manager, Quality Assurance
Direct Reports: This position does not have any direct reports

RESPONSIBILITIES
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1. 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 implement of process changes designed to correct problems noted during trend analyses.

2. Provides QA support for Anti-D Lab and IRBC Manufacturing program. Performs batch review and release.

3.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.

4. Reviews data and reports submitted to support validations. Assures both follow proper cGMPs and SOPs. Maintains laboratory validations and an index of validations stores on site.

5. Provides QA review and release for incoming reagents.

6. Reviews personnel competency assessments to ensure compliance with CSL procedures, SOPs, CLIA and other applicable requirements.

7. Monitors complaints and assures their timely investigation, root cause analysis, resolution and closure. Report trends to Operations and Quality Management.

8 Other job-related duties as assigned.

JOB SPECIFICATIONS
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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

Additional

Comments • N/A

Working
Conditions (physical & mental requirements)
• Shares information with external contacts with common desire to reach a solution
• Understands complex problems to collaborate and explore alternative solutions
• Ability to make decisions, which have significant impact on the department's creditability, operations and services
• Ability to compose letters, outlines, memorandum and basic reports and/or to orally communicate
technical information
• Frequently sitting with a moderate amount of time walking and standing
• Fast paced environment with frequent interruptions

Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.