Senior Specialist, Quality Assurance

Position Description: Senior Specialist, Quality Assurance

Key Responsibilities

• Performs master batch record review and executed batch record review.
• Supports activities for dispositioning drug substance and/or drug products.
• Supports the change management process, ensuring compliance with cGMP.
• Assists in quality investigation of manufacturing deviations.
• Assists in GMP audits, as required.
• Assists in supplier qualification and reassessment activities.
• Supports the QA review of internal and external documentation for compliance with approved documentation, established standards, and regulations.
• Reviews and updates GMP related SOPs and policies
• Participates in projects that support continuous improvement efforts.

· Participate in interactions with external service providers, as applicable.

• Some travel required, domestic and international

Required Experience

• At least 4 years of relevant experience in the area of quality assurance in the Biotech/Life Sciences arena
• Bachelor's degree or higher
• Working knowledge and understanding of ICH and FDA regulations
• Working experience in GMP environment.
• Excellent communication skills, both oral and written.
• Excellent interpersonal skills, collaborative approach essential.

The salary is competitive and commensurate with experience and qualifications.

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.