Advertisement
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
Signature Page 1 of 1
glbdctmp 13 July 2023 4:15:23 PMEST
Approved
Version 2.0 Approved : 31-May-2023 EST CPU-TRG-000169402 docNet
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 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.
CPU-TRG-000169402 (Legacy No.: lc-PD-10254) V2.0 Page 1 of 3
glbdctmp 13 July 2023 4:15:23 PMEST
Approved
Version 2.0 Approved : 31-May-2023 EST CPU-TRG-000169402 docNet
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
Education Associate or Bachelor’s degree in business administration or biological sciences preferred
Experience Strong critical reasoning, decision-making and problem solving skills to analyze situations
This could be Spanish, French, Russian or other non-English languages
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
CPU-TRG-000169402 (Legacy No.: lc-PD-10254) V2.0 Page 2 of 3
glbdctmp 13 July 2023 4:15:23 PMEST
Approved
Version 2.0 Approved : 31-May-2023 EST CPU-TRG-000169402 docNet
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
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
Position Holder: Date:
Print Name:
Signature:
CPU-TRG-000169402 (Legacy No.: lc-PD-10254) V2.0 Page 3 of 3
glbdctmp 13 July 2023 4:15:23 PMEST
Approved
Job Types: Full-time, Permanent
Pay: $42,000.00 - $52,000.00 per year
Benefits:
Experience level:
Schedule:
Work setting:
Ability to commute/relocate:
Experience:
Shift availability:
Work Location: In person