QC Specialist II

Position Title:

QC Specialist II Work Location:

Assignment Duration:

Work Arrangement:

Onsite Position 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.

Key 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 the organization'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 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.
• Can perform technical, root-cause analysis for some software errors.
• Remains up to date on all assigned training activities.

Qualification & Experience:

• Has GMP experience within the pharmaceutical industry.
• Associate's Degree Microbiology, Biochemistry or Related Science Fields.