Processing Lead

KEDPLASMA provides a friendly and rewarding working environment with frequent opportunities for cross-training and advancement. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.

Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

Kedrion Biopharma & KEDPLASMA offer a number of benefits to qualifying employees, including:

• Medical, vision and dental insurance
• Life and AD&D insurance
• Paid holidays
• PTO accrual
• and much more!

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

Please note that salary ranges are calculated based off levels of relevant experience, education and certifications.

JOB SUMMARY

Responsible to ensure accurate and timely processing of unit sampling, storage and compliance of plasma collected from donors while providing oversight of plasma inventory and shipments including submission of sample testing and backup samples, medical supplies and soft goods inventory levels, and Specialty Programs (where applicable) under the direction of the Center Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.

ESSENTIAL JOB FUNCTIONS

Every effort has been made to make your job description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the position if the work is similar, related or is a logical assignment to the position.

MAIN DUTIES AND RESPONSIBILITIES

Core

• Performs sample centrifugation, label control, completion, and inspection.
• Prepares equipment by performing PQ/calibrations and verifying required maintenance has been performed as outlined in the SOPs.
• Performs plasma and sample processing according to cGMPs, Customer Specifications, State and Federal regulations and company policies.
• Responsible for aseptic sampling and heat sealing of plasma units and timely placement of units/samples into freezer per SOPs to ensure product quality.
• Performs troubleshooting of equipment within scope of training.
• Alerts management when equipment poses a risk to donor/product safety.
• Troubleshoots equipment failures, including proper diagnosis and documentation of events to include removing and/or returning equipment to service.
• 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 SOPs.
• Alerts supervisor of processing flow issues.
• Provides support for casing, staging, quarantine, and QA release of all products.
• Facilitates donor flow throughout the plasma collection center with a sense of urgency, minimizing wait time by working carefully and efficiently while reallocating personnel as necessary.
• Alerts management of donor flow issues.
• Explains plasma collection center policies & rules, educates new donors on the use of therapeutic products made from plasma, donation process, tests performed, proper nutrition, donor fee structure, bonuses, center promotions, and any other information pertinent to the donor.
• Maintains alertness for donor reactions and assists with reaction and notifies appropriate Medical Staff as needed.
• Monitors freezer and refrigerator temperatures and immediately informs appropriate personnel if equipment is not functioning properly.
• Performs quality control on various laboratory equipment (e.g., freezer/refrigerator temperatures, Refractometer, HCT, PCS2 Machines, weight scales or other equipment).
• Manages product packing, and inventory within freezers for maximum efficiency.
• Controls disposition of unsuitable product with concurrent documentation.
• Assists in monitoring inventory levels including stockroom and opening and closing of lots for usage.
• Receives inventory and maintains storage area for incoming supplies.
• Prepares product shipment and verification.
• Classifies and documents the product according to donor programs.
• Tracks and records data for plasma Specialty Programs, as needed.
• Reviews donor record files to ensure completeness, accuracy, and compliance with cGMP.
• Communicates with management regarding pertinent information on work areas and continuous improvement opportunities, as needed.
• Provides high level of customer service and strives to meet all production goals.
• Ensures all donor questions are answered timely, accurately, and professionally.
• Maintains a clean, orderly, and efficient work environment and ensures sufficient operating supplies are available as needed.
• Follows all SOPs and regulatory policies and procedures, including the employee handbook.
• Responsible for remaining current on SOPs changes.
• Follows all Health Safety & Environmental and Occupational Safety and Health Administration (OSHA) policies and procedures.
• Maintains data integrity and confidentiality of all personnel, donor, and plasma collection center information.
• Answers the telephone in a courteous manner and provides information or transfer calls to appropriate personnel, as required.

General

Must be able to execute all terms and conditions set forth in the KEDPLASMA Employee Handbook, including, but not limited to:

• Work in a safety-conscious manner which ensures that safe work practices are used in order not to pose a risk to self or others in the workplace.
• Comply with company Global Code of Conduct and company’s policies and procedures and all the applicable regulations.
• Maintain a dependable attendance record and adhere to standards of cleanliness, grooming, hygiene, and dress code.
• Attend and participate in scheduled training, educational classes, and meeting(s) in a timely manner as instructed by supervisor/manager.
• Cooperate with department personnel, as well as other center staff to ensure services can be adequately maintained to meet the needs of the donors.
• Meet with supervisor/manager on a regular basis to assist in identifying and correcting problem areas and/or improving services.
• Complete all assigned tasks in a timely manner as instructed by supervisor/manager.
• Adhere to work schedules in completing and performing assigned tasks.
• Promote KEDRION Values: Together as One; Care; Integrity; Sustainable Impact; and Courage.
• Create and maintain an atmosphere of warmth, personal interest, and positive emphasis, as well as a calm environment.
• Interact in a tactful, diplomatic, and humanistic manner with donors, visitors, and co-workers to provide a safe, efficient, and caring environment which ensures the self-respect, personal dignity, physical safety of each donor and center guest.
• Treat donors, visitors, and co-workers with courtesy, respect, and dignity.
• Perform any miscellaneous duties or work assignments, as required.

PRIMARY CONTACTS

REQUIREMENTS

Education, Qualifications and Experience

• High school diploma, or equivalent, required.
• Minimum of one-year experience in a laboratory or warehouse environment preferred.

Physical Requirements

Work is primarily light in nature, with exerting up to 50lbs of force occasionally and/or a negligible amount of force frequently to lift, carry, push, pull or otherwise move objects. Use of fingers to type and / or enter numbers on keyboards, keypads, etc. along with grabbing object(s). Additionally includes, reaching, handling, talking, hearing, bending, stooping, and walking. Involves sitting, standing, and walking most of the time.

Working Conditions

• Primarily inside with well-lighted and well-ventilated areas.
• Exposure to Blood Borne Pathogens.
• Periodic exposure to an environment with a temperature of -40°C for short periods of time.