GMP Quality Specialist (Contract) 88888

The GMP Quality Specialist supports the implementation of quality assurance principles and ensures compliance with current Good Manufacturing Practices (cGMPs) in a regulated environment. This role involves executing routine QA tasks, supporting investigations, and contributing to continuous improvement initiatives. The ideal candidate will have a strong attention to detail, an understanding of quality systems, and the ability to collaborate effectively in a cross-functional setting.

Key Responsibilities:

• Provide QA support for GMP investigations, change controls, and CAPA processes.
• Participate in compliance initiatives and teams focused on continuous improvement.
• Support development and maintenance of quality documents, including SOPs, protocols, and reports.
• Assist with inspection readiness activities and provide support during audits or regulatory inspections.
• Generate quality metrics and identify trends to support performance monitoring.
• Contribute to ongoing enhancements of QA department processes and systems.

Required Knowledge, Skills & Abilities:

• Solid understanding of cGMP principles in a pharmaceutical or regulated manufacturing environment.
• Ability to collaborate effectively across departments and within cross-functional teams.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• High attention to detail and strong analytical skills.
• Effective verbal and written communication skills.
• Basic experience supporting event investigations, Root Cause Analysis (RCA), and CAPA.
• Familiarity with process improvement methods, gap assessments, and risk evaluations is a plus.

Requirements

Education & Experience:

• Bachelor’s degree in a scientific or allied health field (or equivalent).
• Typically requires 1 year of experience in a quality, regulatory, or GMP-related function, or an equivalent combination of education and experience.

Benefits

• CONTRACT