Change Control Specialist

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

We are seeking a detail-oriented and motivated Entry-Level Change Control Specialist to support change management and quality system activities within the pharmaceutical, biotechnology, and life sciences industries.

The candidate will assist in managing and tracking changes related to manufacturing processes, equipment, facilities, raw materials, documentation, and quality systems. The role involves reviewing change requests, maintaining documentation, coordinating with cross-functional teams, and ensuring that proposed changes are properly evaluated, approved, implemented, and documented in accordance with regulatory and quality requirements.

This opportunity is suitable for recent graduates or candidates with 0–2 years of experience and an academic background in Pharmaceutical Sciences, Pharmacy, Biotechnology, Chemistry, Microbiology, Chemical Engineering, or related fields.

Key Responsibilities

• Change Control Management: Assist in initiating, reviewing, tracking, and maintaining change control requests related to pharmaceutical and biotechnology operations.
• Change Request Documentation: Prepare and maintain change control forms, supporting documents, approval records, and implementation reports.
• Impact Assessment: Support the evaluation of proposed changes to identify their potential impact on product quality, manufacturing processes, equipment, facilities, and regulatory compliance.
• Cross-Functional Coordination: Coordinate with Quality Assurance, Quality Control, Manufacturing, Engineering, Validation, Regulatory Affairs, and other departments to collect required change assessments and approvals.
• Regulatory Compliance: Ensure change control documentation follows Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), SOPs, and applicable regulatory requirements.
• Change Tracking: Monitor open change requests, implementation timelines, pending approvals, and action items to ensure timely completion.
• SOP and Document Updates: Assist in updating Standard Operating Procedures (SOPs), work instructions, specifications, forms, and other controlled documents following approved changes.
• CAPA Coordination: Support the connection between change control activities, deviations, non-conformances, and Corrective and Preventive Actions (CAPA).
• Validation Support: Coordinate with validation teams when changes require equipment qualification, process validation, cleaning validation, or computerized system validation.
• Quality Record Maintenance: Maintain change control logs, electronic records, approval histories, and supporting documentation in the Quality Management System (QMS).
• Audit Support: Assist in preparing change control records and documentation for internal audits, external audits, and regulatory inspections.
• Implementation Verification: Help track implementation activities and collect evidence to confirm that approved changes have been completed as planned.
• Continuous Improvement: Support improvements in change management workflows, documentation accuracy, and quality system effectiveness.

Required Skills

• Bachelor's or Master's degree in Pharmaceutical Sciences, Pharmacy, Biotechnology, Chemistry, Microbiology, Chemical Engineering, or 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.
• Understanding of pharmaceutical manufacturing and laboratory processes.
• Basic computer skills, including Microsoft Excel, Word, and PowerPoint.
• Familiarity with electronic Quality Management Systems (eQMS) is an advantage.
• Strong organizational, analytical, and problem-solving skills.
• Good written and verbal communication skills.
• High attention to detail and ability to manage multiple documentation tasks.

Preferred Qualifications

• Academic projects, internships, or training related to Quality Assurance, Quality Management, or pharmaceutical manufacturing.
• Basic exposure to change control, document control, or CAPA processes.
• Familiarity with FDA regulations, ICH guidelines, and pharmaceutical quality standards.
• Understanding of equipment qualification, process validation, and computerized system validation concepts.
• Exposure to electronic document management systems (EDMS) or eQMS platforms.