QC Analyst III

Job Summary:

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.

Responsibilities

• 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 policies, guidelines and procedures

• Perform other duties as assigned

Skills & Competencies

• 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

Software & Systems Experience

• 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

  • Executing test scripts

• Acts as a SME for at least one software system

• Communicates with cross functional teams to interpret needs and priorities

• Can perform technical, root-cause analysis for some software errors

Education

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