Quality Specialist - CSL Plasma : Job Details

**Job Description Summary**

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

Reporting compliance status data to operational quality management

Collaborate with center management in the development and implementation of continuous improvement plans

Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns

Responsible for coordinating and managing training activities, policies and processes at the center level

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**Job Description**

**1** Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.

**2** Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.

**3** Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.

**4** Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOPs, CLIA/COLA and other applicable requirements.

**5** Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.

**6** Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used

**7** Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues.

**8** Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management.

**9** Identifying and communicate non-conformities to CSLs SOPs. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation.

**10** Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.

**11** Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers.

**12** Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective.

**13** Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable.

**14** Follow all Standard Operating Procedures (SOPs), company policies and procedures.

**15** Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA.

**16** Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.

**17** Assist Plasma center staff in completing other special projects or assignments, as requested.

**18** Perform other job-related duties, as assigned.

**Education**

High school diploma or equivalent required. Associate or Bachelors degree in business administration or biological sciences preferred.

**Experience**

Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment.

Strong customer service skills

Strong critical reasoning, decision-making and problem solving skills to analyze situations

Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives

Understand Quality Systems and/or regulated training requirements

**Working Conditions**

(physical & mental requirements)

Occasionally required to work with the public when they are dissatisfied

80% of the time standing and walking and 20% of the time sitting

Reach, bend, kneel and have high level of manual dexterity

See and speak with customers and observe equipment operation

Occasionally be required to lift and carry 25 lbs.

Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

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.

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CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSLs 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company.

**Our Benefits**

We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care ( at CSL.

**About CSL**

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL ( .

**We want CSL to reflect the world around us**

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion ( at CSL.

**Do work that matters at CSL!**

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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.