QC Analyst 3

JobDiva, Inc.; 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

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.