QC Analyst III

Job Description:

• 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.

Responsibilities:

• 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.
• 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: Track Wise 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 client DI policies guidelines and procedures.
• Perform other duties as assigned.

Requirements:

• Associates degree Microbiology Biochemistry or Related Science Fields.
• 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.