Junior Change Control Analyst - GMP & QA Focus

Virtue America; United States; On-site; USD 42,000 - 54,000; Full time

Job summary

Virtue America is seeking an Entry-Level Change Control Specialist to support change management and quality system activities in the pharmaceutical, biotechnology, and life sciences industries.

You will assist in managing changes across manufacturing processes, equipment, facilities, raw materials, and documentation while ensuring proper evaluation, approvals, and implementation in line with regulatory requirements.

Qualifications

• Bachelor's or Master's degree in a related field.
• Basic understanding of pharmaceutical quality systems and change management processes.
• Knowledge of GMP, GDP, SOPs, and regulatory documentation practices.
• Familiarity with change control procedures and quality documentation.
• Basic understanding of deviations, CAPA, risk assessment, and non-conformance management.
• Ability to review technical documents and maintain accurate records.

Responsibilities

• Assist in initiating, reviewing, tracking, and maintaining change control requests.
• Prepare and maintain change control forms, supporting documents, and implementation reports.
• Support evaluation of proposed changes for impact on quality and compliance.
• Coordinate with QA, QC, Manufacturing, Engineering, Validation, and Regulatory Affairs.
• Ensure documentation follows GMP, GDP, SOPs, and regulatory requirements.
• Monitor open change requests, timelines, and approvals to ensure timely completion.
• Assist in updating SOPs, work instructions, specifications, and forms.
• Support connection between change control activities, deviations, and CAPA.
• Coordinate validation needs for equipment qualification, process validation, and cleaning validation.
• Maintain change control logs and electronic records in QMS.
• Prepare records for internal and external audits and inspections.
• Track implementation activities and collect evidence of completion.
• Support continuous improvements in change management workflows.

Skills

Quality systems knowledge

GMP/GDP knowledge

Regulatory documentation

Change control procedures

CAPA basics

Documentation management

eQMS familiarity

Analytical skills

Attention to detail

Communication skills

Education

Pharmaceutical Sciences

Chemistry

Biotechnology

Pharmacy

Tools

Microsoft Excel

Microsoft Word

PowerPoint

eQMS

EDMS

Job description

Virtue America is seeking an Entry-Level Change Control Specialist to support change management and quality system activities in the pharmaceutical, biotechnology, and life sciences industries.

You will assist in managing changes across manufacturing processes, equipment, facilities, raw materials, and documentation while ensuring proper evaluation, approvals, and implementation in line with regulatory requirements.