Job description

Sagent Pharmaceuticals – Raleigh, NC
*_Technical Transfer Specialist
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The Technical Transfer Specialist will assist with the execution and management of technical transfer projects.
Responsibilities include:

• Use MS Project and other project management tools to help develop and follow up on the project schedule
• Create change controls associated with projects as well participate and author project risk assessments
• Create Process Performance Qualification Protocols, participate inexecution of PPQ batches and coordinate sampling and transport of samples related to PPQ batches
• Summarize data and write final reports and author and revise Master Batch Records
• Develop and revise Standard Operating Procedures
• Communicate and coordinate with other departments and ensure productions needs are met
• Work in all areas of manufacturing maintaining gown qualifications and proper aseptic techniques

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Candidate Requirements:_

• Bachelor’s degree in Science or Engineering field or equivalent experience
• 1-3 years of pharmaceutical industry experience
• Ability to learn new processes and equipment independently
• Good problem solving and critical thinking skills
• High mechanical aptitude and ability to learn and understand new technical information
• Proficient in Microsoft Office (MS Project, Word, Excel, etc.)
• Ability to understand quality systems and GMP requirements
• Ability to gown and work on the production floor in an aseptic manufacturing environment

Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

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Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation._

Job Type: Full-time

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