100% On site Pay Rate ***/hour SAME JOB AS LZAJP00006337 - MANAGER WAS NOT INTERESTED IN CANDIDATES SUBMITTED TO THAT JOB, SO PLEASE DON'T RESUBMIT TO THIS ONE. The Quality Control Technical Transfer Analyst 3 will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activities. Also participate in quality testing for customer in-process, final product testing and stability studies when needed. Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. " Applies job skills and company's policies and procedures to complete a variety of tasks. " Running test samples for In-Process, Lot Release and Stability studies. " Running test samples for (but not limited to) investigations, transfers and validations. " Reviewing assays " Training others " Has experience with: Change Control, Deviations, CAPAs, Tasks, EICRs, Investigations. Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods " Projects such as method transfers, new instruments, method qualifications " Use of Microsoft Suites (Word, Excel, PowerPoint) " Use of Laboratory computer systems " Potential previous use of GMP Quality Systems such as: TrackWise, LIMS " Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. " Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. " Apply Data Integrity principles in all aspects of work, in compliance with *** DI policies, guidelines and procedures. " Perform other duties as assigned. " Strong ability to speak publicly. " Strong ability to interpret data both alone and with guidance. " Perform assigned, complex and/or varied tasks. " Prioritization and problem solving. " Comprehend and follow instructions. " Direct, control and plan tasks/projects. " Brainstorming " Strong ability to communicate in both written and verbal format . " Exercises judgment within defined procedures and practices to determine appropriate action. " Self-motivated team player " Completes assignments on-time and accurately " Displays commitment to quality and performs job functions to the best of his/her ability " Relate to others in a team setting. " Maintain positive attitude in a team environment. " Timeliness in completing assigned tasks. " Works entire assigned shift, including arriving on time Has experience with or currently uses the following software: SoftmaxPro, Empower, SoloVPE Has experience with software validations including but not limited to: writing GMP procedures and validation documents and executing test scripts. Acts as a SME for at least one software system Communicates with cross functional teams to interpret needs and priorities. Has GMP experience within the pharmaceutical industry Can perform technical, root-cause analysis for some software errors Applies Data Integrity principles in all aspects of work, in compliance with *** DI policies, guidelines and procedures. Remains up to date on all assigned training activities. Performs other duties as assigned. Associate s Degree Microbiology, Biochemistry or Related Science Fields
Job Title
QC Specialist II