Senior Quality Control Analyst

Job Description:

The Quality Control Analyst will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activities.

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.

• Applies job skills and company's policies and procedures to complete a variety of tasks.

• Has experience with or currently uses the following software:
• SoftmaxPro, Empower, SoloVPE
• Has experience with method or 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.
• 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 policies, guidelines and procedures.
• Remains up to date on all assigned training activities.
• Performs other duties as assigned.

Has experience with:

• • Use of Microsoft Suites (Word, Excel, PowerPoint)
• • Use of Laboratory computer systems
• • Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
• • Apply Data Integrity principles in all aspects of work, in compliance with policies, guidelines and procedures.
• • Strong ability to interpret data both alone and with guidance.
• • Perform assigned, complex and/or varied tasks
• • Comprehend and follow instructions.
• • Direct, control and plan tasks/projects.
• • Strong ability to communicate in both written and verbal format .
• • 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.
• • Works entire assigned shift, including arriving on time