Let’s do this. Let’s change the world. In this role as Senior Associate QA, you will be working in a shift system; you will be mainly responsible for providing QA guidance and support to ATO Drug Substance production. Next to that, you will provide support in different QA related projects/systems. In this role, you will be in direct contact with a wide range of partners, and you will be accountable for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering. This role will require local presence at the ATO site.
Responsibilities
Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
Ensure purposeful presence in drug substance areas to provide oversight to GMP operations and quality systems.
Act as a first point of contact in case of production queries (quality related) during DS operations.
Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.
Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place
Compile and review batch records for lots manufactured in preparation for batch disposition.
Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms
What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
Basic Qualifications
Master’s degree
Or
Bachelor’s degree and 2 years of Quality experience
Or
Associate’s degree and 6 years of Quality experience
Or
High school diploma / GED and 8 years of Quality experience
Preferred Qualifications
Quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment