QC Specialist 2

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 customers, in-process, final product testing, and stability studies when needed. Applies job skills and the company's policies and procedures to complete a variety of tasks of increased scope. Works on assignments that are semi-routine in nature, where the ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of the situation or data requires a review of identifiable factors.

• Applies job skills and the 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, and method qualifications
• Use of Microsoft Office (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 the ability to recognize deviation from accepted practice is required.
• Works on problems of moderate scope in which analysis of the situation or data requires a review of identifiable factors.
• Apply Data Integrity principles in all aspects of work, in compliance with the Client's 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 formats.
• 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 a positive attitude in a team environment.
• Timeliness in completing assigned tasks.
• 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 an 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 Client's DI policies, guidelines, and procedures. Remains up to date on all assigned training activities.
• Performs other duties as assigned.

Education:

• Associate's Degree Microbiology, Biochemistry or Related Science Fields

Contact: Sunny Rajput | View email address on click.appcast.io