Plasma Classification Sr. Inspector
NC-Clayton, US
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
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Plasma Classification Senior Inspector
Summary:
This position requires a full understanding and knowledge of the Plasma Classification department which includes Master Schedule shipping and target dates and clear understanding of Industry and compliance to operating standards. The right person for this job will have full knowledge of the Classification databases to logically reason and use problem-solving skills to work through problems and find solutions. Further responsibilities may include startup and shut down of the Automatic Conveyor system and expediting the day’s work schedule. The position further requires handling and processing unsuitable plasma units per disposition order. Employee must be able to reconciliation of all units processed by using the Plasma Management System (SGP).
Responsibilities:
1. Working knowledge of Production Unit (PU) processing steps using the Plasma Management System (SGP).
2. Responsible for scanning and inventorying of plasma units assigned to a production unit (PU) utilizing a barcode reader.
3. Responsible for identifying and removing units according to various rejection criteria found during visual inspection.
4. Responsible for disposition, classification, and processing of unsuitable plasma units that are marked for removal during any step of the plasma process
5. Responsible for identifying and blocking units from further production when units fail to meet customer requirements.
6. Responsible for identifying unreleased units and transferring those units into sub shipments during the PU process
7. Responsible for verification of sub-shipment identification and location at the end of the PU process.
8. Responsible for identifying and entering abnormalities into SGP via the “Statistics” function, during or after the PU process
9. Responsible for completing the partial case between PUs
10. Responsible for clearing the production line of all material processed in a completed PU before starting the next PU process.
11. Responsible for transferring units between PUs and from a LOT to a PU.
12. Responsible for the scanning of case/units to a 3rd party sale utilizing the Disposition Module in SGP
13. Responsible for the scanning of case/units for a Material Destruction Order (MDO) utilizing the Disposition Module in SGP
14. Responsible for scanning of archive sample vials assigned to a Sample Archive (SA) utilizing a barcode reader.
15. Responsible for ensuring plasma does not exceed the allowable time out of freezer during production, utilizing the SGP warning system.
16. Able to maintain record accountability and demonstrate accuracy
17. Responsible to reprint labels as necessary from SGP
18. Responsible for using reporting database to print all necessary paperwork to facilitate the beginning of work on a PU
19. Working knowledge of Human Machine Interface (HMI) to set stacking patterns for different types of plasma cases
20. Responsible to account for all production paperwork, including ensuring the correct number of case labels were provided to be used for production.
21. Responsible to distribute and allocate labels according to the number of stations in operation.
22. Responsible for using SGP and working with other areas to ensure that the correct pallets are readily available for the current and upcoming PU’s.
23. Accountable for the number of unused production labels and requesting of overlay labels for disposition material
24. Ability to interpret and follow written procedures.
25. Able to perform job duties with minimal supervision and consistently meet department throughput.
26. Ability to train new and current employees utilizing documented training guidelines.
27. Responsible for updating department reports (Liter Throughput Model, attendance, WIP schedules and further department tracking).
28. Perform the reconciliation process to End Classification for a PU. Using reporting database for any other verification needed to close PUs (e.g. illegible/missing volume, split shipments, or Shipment Cancellation/Reprocess.
29. Add newly created PU folders from Logistics PU List tab and update “Plasma Processing Weekly Schedule” daily.
30, Able to find, report, and assist in correcting potential Inspector errors.
31, Responsible for operating Automatic Conveyor System (e.g. startup, end of shift, troubleshooting alarms, shut down robot).
32, Ability to cross train in the Material Handling department to ensure efficient plasma operations. This requires working in cold environments.
33. Responsible for maintaining CGMP compliance by insuring a high level of cleanliness and organization.
Education:
High School Diploma or GED
KSAs:
1. Possess the ability to listen to and understand information presented through spoken words and sentences. And perform within the guidance of both oral and written instructions.
2. Possess basic math skills (addition, subtraction, division, multiplication).
3. Navigate and understand Microsoft Word/Excel, using Outlook Email, Microsoft Teams, and understand file management
4. Able to make fast simple movements of hands and arms to maintain work pace to meet production standards.
5. Exceptional focus to detail.
Experience:
1. Three years experience in Manufacturing, Pharmaceutical or other FDA licensed Industry or documented and demonstrated abilities to meet requirements through the department curriculum based qualifications is required.
2. Knowledge of cGMPs and Industry Standards.
3. Ability to follow “Standard Operating Procedures”.
Occupational Demands:
1. Able to lift 25 lbs. repeatedly.
2. Ability to perform repetitive functions with high level of concentration.
3. Work is performed while standing for the entire shift. 4. Repetitive/Frequent hand and arm movement of both hands.
5. Exposure to cold temperature using personal protective equipment, cold gear, gloves, and safe shoe.
6. Work is performed in a temperature-controlled warehouse setting.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton
