Quality Assurance Specialist

Key Responsibilities:

• Oversee environmental and facilities monitoring programs, ensuring data integrity and compliance with regulatory expectations.

• Review and interpret data supporting manufacturing and facility operations to ensure accuracy and alignment with quality standards.

• Maintain robust sampling and testing programs for raw materials, aligned with the current stage of the product lifecycle.

• Lead cross-functional teams in investigating and resolving facility deviations and excursions.

• Manage and approve quality system records including change controls, deviations, CAPAs, supplier quality documents, training records, and other controlled documentation.

Qualifications:

• Bachelor’s degree in a relevant scientific or technical discipline.

• 8–10 years of experience in GMP-regulated clinical or commercial manufacturing environments, with a focus on Quality Assurance.

• Strong knowledge of FDA, EMA, and other global regulatory requirements.

• Hands-on experience with quality systems, documentation practices, and supplier quality programs.

• Proven ability to lead continuous improvement initiatives and facilitate cross-functional collaboration.

• Effective project management and team leadership skills.