Processing Technician Group Leader

2 weeks ago

Laredo, United States BPL Plasma Full time
A Career that Makes a Difference

Key Accountabilities

1. Follows all SOPs and regulatory policies and procedures, employee handbook and responsible for remaining current on SOP changes.
2. Attend Staff Meetings and other team meetings, as required.
3. Lead teammates in a manner that maximizes a high level of customer service and strives to meet all production goals. Ensures all donor and employee questions are answered timely, accurately and professionally.
4. Facilitates donor flow throughout the center with a sense of urgency,
minimizing wait time by working carefully and efficiently while reallocating
personnel as necessary. Alerts Supervisor of donor flow issues.
5. Maintains a clean, orderly and efficient work environment and ensures
sufficient operating supplies are available as needed. Responsible for verifying and changing supply lot numbers when a new lot number is introduced into production.
6. Follows all Health Safety Environmental and Occupational Safety and
Health Administration (OSHA) policies and procedures.
7. Prepares equipment by performing PQ/calibrations and verifying required maintenance has been performed as outlined in the SOP.
8. Maintains data integrity and confidentiality of all personnel, donor and center information.
9. Explains center policies rules, educate employees and donors on the use of therapeutic products made from plasma, donation process, and any other information pertinent to the donor experience.
10. Responsible for aseptic sampling and heat sealing of plasma units and timely placement of units/samples into freezer per SOP to ensure product quality.
11. Ensures only one plasma unit and samples are properly labeled at a time and performed within the areas of unidirectional flow designated for each task according to SOP.
12. Maintains plasma inventory controls which could include unsuitable plasma units and samples, according to SOP's. Scans samples into MailDocs. Ensures freezer(s) are clean and well organized.
13. Monitors freezer and refrigerator temperatures and immediately informs
appropriate personnel if equipment is not functioning properly.
14. Tracks and records data for specialty plasma programs, as needed.
15. Ensures daily case management is completed.
16. Ensures samples and units are packed and shipped in accordance with SOPs and center procedures. Prepares shipping and unit disposal documentation.
17. Responsible for removing plasma inventory during shipments.
18. Documents biohazard waste disposal logs.
19. Ensures storage room is well organized to monitor medical supplies and softgood inventory, reporting reorder needs to Supervisory or Management.
20. Performs troubleshooting of equipment within scope of training. Alerts
Supervisory or Management when equipment poses a risk to donor/product safety. May be required to troubleshoot equipment failures, including proper diagnosis and documentation of events to include removing and/or returning equipment to service.
21. Coordinates breaks and lunches to ensure proper area coverage at all times.
22. Supports Center Supervisor by providing input in staff scheduling that ensures adequate level of cross training with the Training Coordinator.
23. Conducts error investigations and develops recommendations for process improvement.
24. Maintains alertness for donor reactions and assist with reaction or notifies appropriate Medical Staff.
25. Provides guidance about processes and technical procedures issues to Plasma Processing Technicians, Senior Plasma Processing Technician, and other staff as required.
26. May be cross trained to meet needs of business.
27. Answers the telephone and provides information or transfer calls to
appropriate personnel.
28. Other job-related responsibilities, as required.

Qualifications

1. Must possess high school diploma or equivalent required.
2. Minimum of one-year experience in laboratory or warehouse environment preferred or equivalent combination of education and experience. Previous experience or hobbies that involve manual dexterity preferred.
3. Consistent work history in any industry acceptable as skills will be trained onthe-job.
4. Good communication and organizational skills.
5. Perform in a manner that supports Company Core Values.

Physical and Mental Working Conditions

1. Frequently performs work while walking or standing.
2. Comfortable being near human blood. Frequently exposed to bloodborne pathogens and may be required to wear personal protective equipment.
3. Must be comfortable performing repetitive duties as outlined in standard
operating procedures.
4. Frequently exposed temperatures > 30o C and may be required to wear
personal protective equipment.
5. Works in an environment with no distractions (radio, iPod, etc.) and with
minimal human interaction while processing units.
6. May be required to work flexible work schedule, including weekends and
holidays.
7. Occasionally required to lift, push and pull up to 25 pounds.
8. Required to communicate and interact with employees and donors.

Specific Responsibilities/Duties

Purpose

The Processing Technician Group Leader is responsible to ensure accurate and timely processing of unit sampling, storage and compliant plasma collected from donors. Provide direct oversight of plasma inventory, plasma shipments, sample testing submission, backup sample submissions, medical supplies and softgood inventory levels and Specialty programs (if applicable). They may assist the Center Supervisor with scheduling, employee counseling, and other duties. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA
cGMP 21CFR.

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