Principal Quality Assurance Specialist

Job Title: Principal Quality Assurance Specialist

Salary Range: $85,000 - $95,000 Bonus & Excellent Benefits

Position Overview:

We are seeking a highly experienced Principal Quality Assurance (QA) Specialist to lead and ensure the highest standards of quality compliance across our site. In this pivotal role, you will oversee all daily QA activities, guaranteeing adherence to internal procedures, GMP standards, and regulatory requirements. This position offers a unique opportunity to influence quality operations, mentor team members, and support continuous improvement initiatives in a fast-paced, innovative environment.

Key Responsibilities:

• Regulatory & Compliance Oversight: Provide continuous, strategic oversight of all quality activities, ensuring strict compliance with GMP and regulatory standards. Review and approve site documentation, including batch records, SOPs, and change requests, maintaining meticulous records for audit readiness.
• Product and Documentation Management: Approve finished product dispositions and Certificates of Analysis (CoA). Manage and review Bill of Materials (BOMs), inspection plans, calibration records, and related documentation to maintain accuracy and compliance.
• Investigations & CAPA: Lead or participate in cross-functional investigations of deviations, non-conformances, and CAPA initiatives. Ensure timely resolution, root cause analysis, and implementation of corrective and preventive actions, with thorough documentation.
• Audit & Inspection Support: Lead internal and external audits, prepare comprehensive audit reports, and facilitate audit findings resolution. Support regulatory inspections with detailed documentation and proactive responses.
• Training & Mentorship: Assist in training QA team members and other departments on quality standards, SOPs, and audit procedures to foster a culture of quality excellence.
• Continuous Improvement & Data Analysis: Support the Annual Product Review (APR) process by collecting and analyzing batch data. Monitor and trend CAPA metrics, customer complaints, change controls, and vendor issues to drive process improvements.
• Documentation & System Management: Maintain and improve the Document Control System, including review, approval, and archiving of documents. Support electronic Document Management System (eDMS) activities—including document routing, revision management, and retrieval.
• Additional Responsibilities: Conduct internal audits, oversee obsolete material destruction, perform packaging line inspections, and support vendor qualification and approval processes. Assist in special projects and initiatives assigned by QA management.

Qualifications & Skills:

• Bachelor’s degree in Life Sciences, Engineering, or related field preferred.
• Minimum of 10 years of QA experience within GMP-regulated environments.
• Extensive knowledge of GMP regulations, FDA, EMA, and other relevant standards.
• Proven experience leading audits and managing CAPA processes.
• Strong analytical skills with the ability to interpret complex data.
• Excellent communication skills and the ability to collaborate effectively across departments.
• Proficiency with electronic Document Management Systems and quality systems.

Why Join Us?

This role offers a compelling blend of leadership, technical expertise, and strategic impact—ideal for highly motivated QA professionals looking to advance their careers in a dynamic setting.