Tech Transfer Analyst

• Serves as the Study Director for the Continued Process Verification (CPV) program (SOP 10-01-03-0182) at the site.
• Tracks batch history for each product code/family using an Excel spreadsheet or other tracking mechanism.
• Works with other TT staff to generate Risk Assessments identifying product critical quality attributes when necessary.
• Plans, coordinates, and oversees the Manufacturing Process Council (MPC) including scheduling and summarizing monthly meetings.
• Communicates as necessary with the various plant departments, other support departments, and council team members.
• Supports product life cycle through execution of continued process verification reports
• Coordinates the initiation and tracking of Material Change Requests (MCRs) applicable to the site.
• Provides support, information and documentation needed for regulatory submissions or responses as required.
• Provides technical assessment of changes in manufacturing through appropriate review of documentation and testing results.
• Assumes additional duties and responsibilities as assigned by management

• Minimum of a bachelor's degree in physical science, engineering, or equivalent experience.
• 1-3 years experience with manufacturing, quality control, statistical analysis or product transfer assignments that demonstrate tenacity to see projects through to completion according to established action plan; analytical skills necessary for problem solving issues as they arise.
• Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment.
• Effective oral and written communication skill set. Requires proficient presentation and technical writing abilities.
• Experience using eDMS, KabiTrack, and LIMS or other equivalent systems.
• Knowledge of pharmaceutical manufacturing processes, statistical processes, validation, cGMP's, and FDA regulations for the Pharmaceutical Industry.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.