Version 2.0 Approved : 31-May-2023 EST CPU-TRG-000169402 docNet

Signature Page

CPU-TRG-000169402

Quality Specialist

Signed By: Date (GMT):

Smith, Wendy 25-May-2023 19:29:56

Approved-Quality

Coleman, John 31-May-2023 12:59:57

Approved-Author

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Position Description

POSITION INFORMATION

Position Title: Position Location:
Quality Specialist Collection Centers

Business/Functional Unit: FLSA Status: Date:
Plasma Operations Non-Exempt November 2016

GENERAL SUMMARY
State the general nature and most important job aspects

This position provides immediate support to the Assistant Manager 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 Quality Manager (AQM), 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

REPORTING RELATIONSHIP
List positions that report into this position and to whom this position reports

Reports To: Assistant Manager of Quality or Quality Manager

Direct Reports: This position does not have any direct reports

RESPONSIBILITIES
List current duties and responsibilities

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

Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate

2 investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.

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

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

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

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

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

Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to
8 ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management.
Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly

9 quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation.

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

Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP,
11 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.

Maintain clean efficient work environment. Comply with all Environmental Health & Safety (EHS) and Occupational
13 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 Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.

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

19 Perform other job-related duties, as assigned.

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

• High School diploma or equivalency required

Education Associate or Bachelor’s degree in business administration or biological sciences preferred

• Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment
• Strong customer service skills

Experience 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
• Minimum travel required
• Bilingual skills preferred, at the discretion of the organization to meet the needs of the business.

This could be Spanish, French, Russian or other non-English languages

• Work in a fast paced, dynamic environment
• Learn new processes and quickly engage in assignments to drive for action

Additional Attention to detail and ability to follow written and verbal directions in exact detail required

Comments Frequently required to make and accept modifications to working processes and procedure per SOP

• Make decisions in accordance with established policies and procedures
• Exercise independent and good judgment to refer decisions when decisions fall out to the realm of established guidelines
• Lead teams without the benefit of a direct reporting relationship
• Maintain technical competencies in all areas

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• 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.

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

Conditions various odors

(physical & Exposure to human source products and various chemicals including isopropyl, ethyl alcohol,

mental carbon dioxide, iodine, bleach, germicide solution, etc.

requirements) Required to wear Personal Protective Equipment while performing specific tasks or in certain areas

• Work in 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.

NAMES, SIGNATURES and DATES

• Disclaimer: * The above statements describe the general nature and level of work and are not an exhaustive list of all required responsibilities, duties, and skills.*

Position Holder: Date:

Print Name:

Signature:

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Job Types: Full-time, Permanent

Pay: $42,000.00 - $52,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Experience level:

• 1 year

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift
• Day shift
• Holidays
• Monday to Friday
• Night shift
• Overtime
• Weekends as needed

Work setting:

• In-person
• Office

Ability to commute/relocate:

• Hyattsville, MD 20785: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Required)
• Night Shift (Required)

Work Location: In person