Senior Associate QA

Lets do this. Lets 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.

• 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

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.

Masters degree

Bachelors degree and 2 years of Quality experience

Associates degree and 6 years of Quality experience

• Quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelors Degree in a Science Field
• Ability to successfully manage workload to timelines
• Familiarity with basic project management tools
• Demonstrated ability to consistently deliver ontime and highquality results
• Ability to operate in a matrixed or team environment