QA Specialist

We are seeking a Plant Technician Quality Assurance (PTQA) Specialist to join our clients team. This senior QA role is ideal for someone with a strong technical foundation in aseptic process validation, technology transfer and new product introduction.

Key Responsibilities

• Act as the Quality point of contact and decision-maker during New Product Introductions, Technology Transfers, and Process Validation activities for aseptic products, ensuring full compliance with regulatory expectations.
• Review and approve Process Development and Validation documentation, including technical transfer documents, validation protocols, and executed reports.
• Provide Quality direction and input at Change Control and Deviation Review Boards, maintaining QA oversight of all change control and Deviation/CAPA records.
• Ensure all records are clearly scoped, with timely and robust implementation of activities.
• Perform all responsibilities in strict compliance with the clients safety standards, procedures, and SOPs.
• Support continuous improvement by collaborating across cross-functional teams and adapting responsibilities in line with evolving business needs.

Preferred Qualifications

• 7+ years in a QA or validation-focused role within the pharma/biotech sector
• A degree in Science or Engineering (preferred)
• Deep understanding of Validation, NPI, and aseptic manufacturing
• Proven ability to lead within Deviation/CAPA/Change Control processes
• Strong critical thinking and cross-functional communication skills
• Comfortable working independently and remotely
• A team-oriented mindset, with confidence to challenge and collaborate