QA Specialist - I

ALTEN; Morris Plains (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Quality Assurance professional to ensure compliance with GMP standards and support manufacturing operations. The role involves overseeing quality processes, troubleshooting issues, and participating in audits. Ideal candidates will have relevant GMP experience and a degree in a related field.

Qualifications

• 2+ years of GMP experience with a BS degree, or 3+ years with an AA degree.
• Prior pharmaceutical industry experience is preferred.

Responsibilities

• Coordinate Quality Oversight within Drug Product operations.
• Conduct investigations and corrective actions.
• Support manufacturing operations to address quality issues.

Skills

Quality Oversight

Compliance

Troubleshooting

Process Improvement

Education

BS Degree

AA Degree

Job description

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• Quality Assurance delivers on our commitment to bring life-changing therapies to patients through robust QA processes and systems. Our approach is agile, innovative, and collaborative. Our teams are genuinely committed to the rapid delivery of safe, life-changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

Job Description

Quality Assurance plays a key role in ensuring the quality and compliance of our pharmaceutical products. The team is responsible for maintaining GMP standards and supporting manufacturing operations to deliver safe therapies efficiently.

Essential Duties and Job Functions

• Coordinate and manage on-the-floor Quality Oversight within commercial Drug Product operations to ensure compliance with GMPs and regulatory readiness.
• This is a 1st shift position; hours may be Monday-Friday.

Primary Responsibilities

• Provide Quality oversight to shop floor operations, supporting upstream and downstream manufacturing at real time.
• Advise on quality issues as they arise during plant operations.
• Identify, troubleshoot, and escalate non-compliance issues and events.
• Conduct investigations, CAPAs, and corrective actions.
• Prioritize and manage multiple projects effectively.
• Ensure compliance with policies and procedures.
• Support material inventory, status, and transfers.
• Assist with changeovers in production areas.
• Participate in audits and other projects.
• Support manufacturing operations to address product quality and compliance issues.
• Review production documentation for adequacy and compliance.
• Participate in process improvement initiatives focusing on documentation accuracy (Right First Time).
• Organize and attend cross-functional meetings related to event resolution and CAPAs.
• Implement and adhere to regulations and Gilead quality standards.
• Promote a Quality Culture and safe working environment.
• Complete required job-related training.

Knowledge, Experience, and Skills

• 2+ years of relevant GMP experience with a BS degree, or 3+ years with an AA degree.
• Prior pharmaceutical industry experience is preferred.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Other
• Industries: IT Services and IT Consulting