Senior QA for QC Specialist

Job summary

This role involves providing quality assurance support to the quality control (QC) laboratory in a growing production site. The Senior QA for QC Specialist will engage with various stakeholders to enhance compliance and ensure quality oversight.

Qualifications

• Over 10 years of relevant experience in quality assurance or a related field.
• Strong understanding of GxP guidance and quality systems.
• Ability to thrive in a dynamic work environment.
• Excellent communication and organizational skills.
• Experience with method technology transfers, deviations, and changes is preferred.

Responsibilities

• Provide QA support to QC and QC-AD.
• Review and approve method technology transfer documents and QC-related documentation.
• Assess and approve changes and deviations.
• Ensure compliance with procedures and documentation standards.
• Act as a quality partner, offering guidance and training to stakeholders.
• Represent QA for QC on assigned projects.
• Contribute to alignment tasks within QA for QC.
• Maintain training levels and stay updated on cGMPs and regulatory requirements.

Education

• A Bachelor’s or Master’s degree in a natural science (e.g., Pharmacy, Biotechnology, Biology, Engineering) is preferred but not mandatory.