Quality Specialist: GMP Compliance & Investigations

Actalent; Cherry Hill Township (NJ); On-site; USD 44,000 - 48,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

HSA

Transportation benefits

Employee Assistance Program

PTO / Vacation or Sick Leave

Job summary

Actalent is seeking a Quality Specialist to ensure accurate, compliant quality documentation and to support investigations, deviations, and customer complaint management in a regulated pharmaceutical environment.

The role focuses on documenting findings, reviewing batch records for GMP compliance, and collaborating with cross-functional teams to uphold quality processes and continuous improvement initiatives.

Qualifications

• Bachelor's degree in Science or a related field.
• 45+ years of experience in a pharmaceutical quality role.
• Strong understanding of GMP principles and their application in a pharmaceutical setting.
• Hands-on experience with investigations related to quality issues.

Responsibilities

• Complete quality documentation accurately and in a timely manner, including investigation reports and deviation records.
• Review batch records to ensure GMP compliance and internal quality procedures.
• Assist in investigations of quality issues, deviations, and nonconformances, and document findings and corrective actions.
• Support management and resolution of customer complaints by gathering data and conducting root cause analysis.
• Collaborate with cross-functional teams to ensure consistent QA processes.
• Participate in validation activities by reviewing documentation to confirm regulatory compliance.
• Contribute to continuous improvement by identifying trends in investigations and recommending process enhancements.
• Maintain audit-ready quality records and documentation according to regulatory expectations.

Skills

GMP principles

Investigations

Deviation management

Quality documentation

Root cause analysis

Customer complaints handling

Batch record review

Attention to detail

Cross-functional collaboration

Education

Bachelor's degree in Science

Job description

Actalent is seeking a Quality Specialist to ensure accurate, compliant quality documentation and to support investigations, deviations, and customer complaint management in a regulated pharmaceutical environment.

The role focuses on documenting findings, reviewing batch records for GMP compliance, and collaborating with cross-functional teams to uphold quality processes and continuous improvement initiatives.