QC Specialist II

Responsibilities

• Running test samples for In-Process, Lot Release and Stability studies.
• Running test samples for investigations, transfers and validations.
• Reviewing assays.
• Training others.

Qualifications

• 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.

Skills

• Strong ability to speak publicly.
• Strong ability to interpret data both alone and with guidance.
• Perform assigned, complex and/or varied tasks.
• Prioritize and solve problems.
• 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 a positive attitude in a team environment.
• Timeliness in completing assigned tasks.
• Works entire assigned shift, including arriving on time.
• Experience with or currently uses the following software: SoftmaxPro, Empower, SoloVPE.
• 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.
• GMP experience within the pharmaceutical industry.
• Performs 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.

Benefits

Remains up to date on all assigned training activities.