QC Specialist II

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 companys 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 companys 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.

Associates Degree Microbiology Biochemistry or Related Science Fields