Laboratory Quality Systems Specialist

GENERAL SUMMARY

State the general nature and most important job aspects 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

List positions that report into this position and to whom this position reports Reports To: Manager, Quality Assurance Direct Reports: This position does not have any direct reports

RESPONSIBILITIES

List current duties and responsibilities

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

Provide minimum hiring requirements, specialized knowledge, and other considerations required

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.

About CSL Plasma CSL Plasma operates one of the world’s largest and most sophisticated plasma donation networks, with nearly 330 donation centers in the U.S. and Europe. CSL Plasma is a subsidiary of CSL, a global biopharma company. Plasma collected at CSL Plasma facilities is used by CSL for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 29,000+ people. Learn more about CSL Plasma here https://www.cslplasma.com/ and CSL, CSL Behring, CSL Seqirus and CSL Vifor here https://www.csl.com/. Learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor here at https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp.

You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.