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TPR Career Descriptions
Successful candidates will have experience in the medical field as well as SOPs and GMP experience and experience working in a compliance environment. Plasma Center experience is also preferred.
Talecris Plasma Resources offers a competitive compensation and benefits package and we're proud of our work/life/blalance initiatives. An Equal Opportunity Employer M/F/D/V, Talecris Plasma Resources is committed to enhancing and maintaining cultural diversity within our work environment.
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Corporate Assistant Trainer
Administers technical training; ensure the implementation of training strategies and other developmental activities; supports other Donor Center activities to ensure that the staff is properly trained on company policies and Standard Operating Procedures; responsible for the evaluation and determination of an employee’s competence to perform required job functions throughout the training process and with periodic employee observations; ensure that the Center is operating in training compliance with FDA, GHA, OSHA, cGMP and other regulatory authorities as applicable; oversees activities to support all training compliance requirements.
DMS Implementation Specialist
Supervises the installation of the DMS system in plasma centers. Fifth Dimension (5D) Information Management's Donor Management System (DMS) is a validated / regulated Computer System, consisting of a software application, hardware and interfaces, all which automate the business and record-keeping processes of plasma collection operations. You will facilitate the introduction of, and verify the performance and functionality of DMS in newly-opened plasma centers. As centers become automated, you will be called on to provide on-site technical and operations support, verify DMS training records, and identify/assist with special training.
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Donor Processor
Gather donor medical histories and administer initial donor screening to undergo plasmapheresis. Determine initial donor suitability through verification of accumulated data; perform pre-donation medical screening in accordance with established guidelines; perform new donor medical history screening in accordance with established guidelines; maintain all permanent donor files in an organized and efficient manner; perform general administrative duties including greeting donors, answering phones, and assisting center management as needed; maintain thorough familiarity of State and Federal Regulations, the Standard Operating Procedures manual, OSHA, CLIA, cGMP and all internal company procedures.
Physician Substitute
Ensure donor suitability and eligibility, product integrity, and the continued health of donors. Ensure compliance with the Food and Drug Administration regulations and standard operating procedure manual guidelines. Selection of eligible plasmapheresis donors through the use of the standard operating procedure manual, current state and federal guidelines, OSHA, CLIA, and Cgmp, and all internal company procedures; review accumulated data to confirm established donors' continued eligibility; provide appropriate medical care to donors during unexpected or severe reactions to plasmapheresis; assist with management and administration of Hepatitis Vaccine program, according to established protocols.
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Quality Supervisors
Will perform QA functions to ensure internal and external functions are within guidelines. Will oversee all plasma shipments to ensure accurate labeling and documentation; ensure that donor record files are complete and accurate; conduct internal and external audits; ensure that supplies/materials meet requirements, oversee QC checks; and related functions.
Regional HR Manager
Provides strategic client-focused support to the client base, focusing on meeting their operating and long-term strategic objectives through the following activities: implementing business unit/departmental change, providing solutions to business issues utilizing competitor/best practice data/HR tools, processes and diagnostics, taping into HR specialists for unique HR solutions and systems, providing clarification of line management role in HR processes, anticipate business needs, and advocate principles of sound people management practices.
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Regional Operations Manager
Directs the Plasma Donor Center Managers located within assigned geographical area in all aspects of production, personnel, staffing, training, regulatory compliance, budgeting, forecasting, cost, quality, and safety. Assists in the development and implementation of new programs, procedures and positions within assigned centers; provides ongoing assistance with Personnel Practices including staffing, training and employee issues, under guidance from the HR Business Partners; ensures safety in product quality and integrity, donor safety, employee safety and environmental concerns (e.g., infectious waste disposal); develop, monitor and assist in the preparation of center budgets and forecasts, including volume, cost donor panel goals, capital expenditures and operating budgets; assist corporate functions including lease negotiations, capital budgets preparation, strategy planning, center renovation, center relocation and center closings.
Regulatory Affairs Specialist
Evaluate adequacy of documentation and completeness of incident reports such as Product Investigation Reports (PIR) and Medical Incident Reports (MIR); evaluate corrective actions and supporting documentation for PIRs and MIRs and recommend additional actions and information to complete reports; monitor and trend customer complaints, nonconformance, and medical incidents; assist in development of system-wide Corrective Action and Preventative Actions Plans (CAPAs) and related checks where applicable; review notifications of nonconforming material for customer submission; initiate Biological Product Deviation Reports (BPDR) for submission to the Food and Drug Administration (FDA); conduct new hire training on investigation and incident reporting from Corporate RA/QA Manual.
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SMART Team Manager
Responsible for the leadership of a SMART team comprised of the SMART Team Manager, SMART Team Quality, and SMART Team Training. Ultimate responsibility is to guide and manage SMART team in the start-up and development of individual Plasma Donor Centers until defined acceptable competency level are acheived. Role intended as developmental into an operations management role.
Training Supervisor
Deliver, oversee, and monitor training of all employees in the center; responsible for evaluating and determining each IBR employee's competence to perform required job functions. Will also oversee activities to support all training compliance requirements. Required to be certified as a back-up Quality Supervisor and to fulfill that role whenever necessary and provide input on personnel decisions.
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Thank you for your interest in Talecris Plasma Resources. |
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