Pharma QC Analyst: Software Validation & Data Integrity

Katalyst-Healthcares-; Portsmouth (NH); On-site; USD 60,000 - 90,000; Full time

Job summary

JobDiva, Inc. is seeking a Quality Control Analyst to support the QC department and production in technical transfer activities within a pharmaceutical GMP environment.

The role emphasizes laboratory systems, data analysis, software validation, and Data Integrity. Responsibilities include performing GMP-compliant QC tasks, validating methods/software, and acting as SME for key software systems such as SoftMax Pro, Empower, SoloVPE, TrackWise and LIMS.

Qualifications

• Bachelor's degree in a chemical/biological/biochemical or related scientific field.
• 3–5 years in pharmaceutical GMP Quality Control environment.
• Experience with SoftMax Pro, Empower and/or SoloVPE.
• Experience validating methods and software & writing GMP procedures.
• Experience executing validation test scripts.
• Experience with laboratory computer systems & GMP quality systems.

Responsibilities

• Support QC and production activities related to technical transfers.
• Perform QC tasks according to GMP procedures and company policies.
• Work with SoftMax Pro, Empower and SoloVPE.
• Support method and software validation and write validation documents.
• Act as SME for at least one software system.
• Troubleshoot software issues and perform root-cause analysis.

Skills

Data analysis

GMP knowledge

Communication

Problem solving

Attention to detail

Education

Bachelor's degree in Chemistry, Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related field

Tools

SoftMax Pro

Empower

SoloVPE

TrackWise

LIMS

Microsoft Word

Excel

PowerPoint

Job description

JobDiva, Inc. is seeking a Quality Control Analyst to support the QC department and production in technical transfer activities within a pharmaceutical GMP environment.

The role emphasizes laboratory systems, data analysis, software validation, and Data Integrity. Responsibilities include performing GMP-compliant QC tasks, validating methods/software, and acting as SME for key software systems such as SoftMax Pro, Empower, SoloVPE, TrackWise and LIMS.