QC Analyst 3

The Quality Control Analyst will support the Quality Control department and production by contributing to technical transfer activities. The role requires experience in a pharmaceutical GMP environment, laboratory systems, data analysis, software validation, and Data Integrity.

Summary:
The Quality Control Analyst will support the Quality Control department and production by contributing to technical transfer activities. The role requires experience in a pharmaceutical GMP environment, laboratory systems, data analysis, software validation, and Data Integrity.
Roles & Responsibilities:

• Support Quality Control and production activities related to technical transfers.
• Perform assigned QC tasks according to GMP procedures and company policies.
• Work with SoftMax Pro, Empower, and SoloVPE.
• Support method and software validation, including writing GMP procedures, validation documents, and executing test scripts.
• Act as an SME for at least one software system.
• Perform basic technical troubleshooting and root-cause analysis for software issues.
• Apply Data Integrity principles to all work.
• Work with laboratory computer systems and GMP quality systems such as TrackWise and LIMS.
• Use Microsoft Word, Excel, and PowerPoint.
• Analyze and interpret data accurately.
• Communicate effectively with cross-functional teams.
• Complete assignments accurately and on time.
• Follow all GMP, quality, training, and company requirements.
• Maintain reliable attendance and work the complete assigned shift.

Mandatory Experience:

• 3 5 years of experience in a pharmaceutical GMP Quality Control environment.
• Hands-on experience with SoftMax Pro, Empower, and/or SoloVPE.
• Experience with method and/or software validation.
• Experience writing GMP procedures and validation documents.
• Experience executing validation test scripts.
• Experience with laboratory computer systems.
• Strong understanding and application of Data Integrity principles.
• Experience with technical troubleshooting and root-cause analysis for software issues.
• Experience using Microsoft Word, Excel, and PowerPoint.
• Strong written and verbal communication skills.
• Ability to interpret data and follow GMP procedures accurately.

Preferred:

• Experience with TrackWise and/or LIMS and experience acting as an SME for a laboratory software system.

Education:

• Bachelor's degree in Chemistry, Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific/technical field.