Talecris Biotherapeutics Open Job Positions
Aseptic Fill Core Operator Tech II Tech I
Clayton,
North Carolina
Job First Active on:
DIVISION: Talecris Biotherapeutics - Performs a variety of operations involving the support of aseptic filling of plasma products, primarily operation of highly automated fill equipment inside the aseptic environment. Major duties will include operation of the fill/stoppering equipment to dispense sterile product into glass containers, calibration of critical loadcells before, during and after each fill, environmental monitoring of t .. Show Job Details
Aseptic Filling Core Operator Tech II Tech I
Clayton,
North Carolina
Job First Active on:
DIVISION: Talecris Biotherapeutics - Performs a variety of operations involving the support of aseptic filling of plasma products, primarily operation of highly automated fill equipment inside the aseptic environment. Major duties will include operation of the fill/stoppering equipment to dispense sterile product into glass containers, calibration of critical loadcells before, during and after each fill, environmental monitoring of t .. Show Job Details
Associate Director, Regulatory Affairs
RTP,
North Carolina
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DIVISION: Talecris Biotherapeutics - 1. Liaison with regulators on all matters regarding Talecris Plasma Resources. Provide direction to and negotiate with FDA, CLIA/COLA, GHA, and state specific agencies to obtain
pre-clearance of actions and manufacturing of products, respond to FDA
regulatory letters and take action on competitor behavior to support
TPR strategy.
2. Direct reviews of, evaluate, and provide regulatory guidance for .. Show Job Details
Clarification Operator Tech I Tech II
Clayton,
North Carolina
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DIVISION: Talecris Biotherapeutics - Perform all duties associated with receipt of frozen blood plasma, the clarification operation, and AHF Concentrate production. Clean and prepare equipment and facilities associated with the clarification operation. Operate fork truck and pallet mule for transporting plasma and other items for the production of pools. Perform the maintenance of fork truck and pallet mule batteries by charging and .. Show Job Details
IGIV-C Operator, IGIV_C Technician II, IGIV-C Technician I
Clayton,
North Carolina
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DIVISION: Talecris Biotherapeutics - Isolation of IgG Protein by processing plasma intermediate material II + III paste through the dissolution and filtration stage, chromatography purification stage, and ultrafiltration / diafiltration stage, to formulation and sterile bulking as well as preparation of buffers.
Position is a 12 hour rotating shift. .. Show Job Details
Maintenance Tech Master Maintenance Tech II
Clayton,
North Carolina
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DIVISION: Talecris Biotherapeutics - The Maintenance position is responsible for day to day manufacturing support/troubleshooting, equipment enhancements and project support of various equipment at the Clayton site.
Responsibilities include but are not limited to:
• Ensure reliable production area operation in compliance with regulatory and production requirement by performing cGMP calibrations
• Troubleshoot and maintain the produc .. Show Job Details
Medical Device Software Engineer
Raleigh,
North Carolina
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DIVISION: Talecris Biotherapeutics - This position will lead the technical elements of the software development life cycle for selected Talecris internally supported applications, with a primary focus on systems requiring stringent design controls. Responsibilities include:
•Work with cross-functional project teams to identify, capture, and understand requirements
•Generate rigorous system design specifications
•Build applications .. Show Job Details
Medical Director
RTP,
North Carolina
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DIVISION: Talecris Biotherapeutics - The Medical Director will assess clinical feasibility and strategic planning of clinical trial programs/studies in various assigned therapeutic areas. Executes and moderates investigator/medical advisory meetings with clinical experts and serves as the clinical internal expert in the assigned area. Initiates the set up of the clinical study, including generation of final protocols, case report for .. Show Job Details
QA Assistant Associate Biologist
Clayton,
North Carolina
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DIVISION: Talecris Biotherapeutics - The Assistant/ Associate Biologist will perform Routine and Non- Routine biological testing (microbial and endotoxin) of intermediates within the Quality Operations Environmental Assurance In-Process Laboratory. The Biologist will support validation of production tanks, HAS, bottles, rinsers, and autoclaves using established written procedures. The Biologist will perform microbial and endotoxin te .. Show Job Details
QO Supervisor Sr. QO Supervisor I
Clayton,
North Carolina
Job First Active on:
DIVISION: Talecris Biotherapeutics - Incumbent will be responsible for supervising night shift Environmental Assurance (EA) routine and non-routine operations to ensure timeliness, efficiency and accuracy of testing, and to ensure that operations are performed safely and in compliance with cGMP guidelines.
Incumbent will oversee environmental testing of the site Aseptic Fill suites, manufacturing and laboratory facilities, and utili .. Show Job Details
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