Quality Assurance Associate

Virtue America; United States; On-site; USD 45,000 - 60,000; Full time

Job summary

Virtue America is seeking an Entry-Level Quality Assurance Associate to support GMP-compliant quality management activities in the pharmaceutical sector. You will help maintain documentation, review records, and assist investigations under supervision.

This role is ideal for graduates in Pharmacy, Pharmaceutical Sciences, Biotechnology, Microbiology, Chemistry, or related life sciences seeking hands-on experience with quality systems, regulatory compliance, and product assurance.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, Microbiology, Chemistry, Biomedical Sciences, Life Sciences, or related discipline.
• Fundamental understanding of GMP, cGMP, and regulatory compliance.
• Experience with SOPs, batch records, and controlled documentation.
• Knowledge of deviations, CAPA, change control, and non-conformance management.
• Understanding of data integrity and traceability of quality records.
• Proficiency with Word, Excel, and documentation tools.
• Strong attention to detail and organizational skills.
• Good written and verbal communication for reports and cross-functional coordination.

Responsibilities

• Review and maintain batch records and SOPs.
• Support cGMP and GDP compliance.
• Review manufacturing and packaging documentation for discrepancies.
• Document and track quality deviations and investigations.
• Assist CAPA monitoring and corrective action tracking.
• Support document revisions, approvals, and version control.
• Organize quality records for internal audits and regulatory inspections.
• Update quality tracking logs and QMS databases.
• Ensure data integrity and traceability.
• Coordinate with Quality Control, Manufacturing, Regulatory Affairs, and Document Control.
• Identify recurring documentation errors and opportunities for improvement.

Skills

GMP knowledge

Documentation

Data integrity

Attention to detail

Communication skills

Analytical thinking

Education

Bachelor's or Master's degree in Pharmacy/Pharmaceutical Sciences/Life Sciences

Tools

Microsoft Word

Microsoft Excel

Job description

We are seeking a detail-oriented and motivated Entry-Level Quality Assurance Associate to support quality management activities within the pharmaceutical and life sciences industry. The candidate will assist in maintaining quality documentation, monitoring compliance with Good Manufacturing Practices (GMP), reviewing manufacturing and laboratory records, and supporting quality investigations. This role provides an opportunity for recent graduates in Pharmacy, Pharmaceutical Sciences, Biotechnology, Microbiology, Chemistry, or related life sciences disciplines to develop practical knowledge of pharmaceutical quality systems, regulatory compliance, and product quality assurance.

Key Responsibilities:

• Quality Documentation: Review and maintain batch records, Standard Operating Procedures (SOPs), quality forms, and other controlled documents to ensure accuracy and completeness.
• GMP Compliance: Support compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable pharmaceutical quality standards.
• Quality Assurance Activities: Assist in reviewing manufacturing and packaging documentation to identify errors, discrepancies, and deviations from established procedures.
• Deviation Management: Help document and track quality deviations, nonconformances, and investigation records.
• CAPA Support: Assist in monitoring Corrective and Preventive Actions (CAPA) and tracking corrective action completion.
• Document Control: Support document revisions, approval workflows, version control, and record archival activities.
• Audit Preparation: Organize quality documentation and supporting records for internal audits and regulatory inspections.
• Quality System Maintenance: Update quality tracking logs, compliance records, and quality management system databases.
• Data Integrity: Ensure quality records are accurate, traceable, complete, and maintained according to established procedures.
• Cross-Functional Collaboration: Coordinate with Quality Control, Manufacturing, Regulatory Affairs, and Document Control teams to resolve quality-related issues.
• Continuous Improvement: Assist in identifying recurring documentation errors and opportunities to improve quality processes.

Required Skills:

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, Microbiology, Chemistry, Biomedical Sciences, Life Sciences, or a related discipline.
• Basic understanding of GMP, cGMP, pharmaceutical quality assurance, and regulatory compliance principles.
• Familiarity with SOPs, batch manufacturing records, controlled documentation, and document revision practices.
• Basic knowledge of deviations, root cause analysis, CAPA, change control, and non-conformance management.
• Understanding of data integrity principles, including accurate documentation and traceability of quality records.
• Proficiency in Microsoft Word, Excel, and other documentation and reporting tools.
• Strong attention to detail, organizational skills, and the ability to maintain accurate records.
• Analytical and problem-solving abilities to identify documentation discrepancies and potential quality issues.
• Good written and verbal communication skills for preparing reports and coordinating with cross-functional teams.
• Ability to follow established procedures, manage assigned tasks, and meet documentation deadlines.
• Preferred: Academic projects, internships, or coursework involving pharmaceutical manufacturing, quality systems, laboratory practices, GMP documentation, or regulatory affairs.