Quality Assurance Specialist
We are seeking a Quality Assurance Senior Specialist to oversee all validation activities ensuring compliance with current regulatory requirements, c GMP and company SOPs.
This role is responsible for the oversight of all validation activities including facilities, utilities, equipment, computerized systems, cleaning processes, storage areas, controlled temperature units (CTUs) and shipping. The successful candidate will be responsible for ensuring the quality oversight of qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
The ideal candidate will have thorough understanding of the validation requirements associated with a c GMP manufacturing facility knowledge of Gx P regulations applicable to biologics manufacturing. They will also possess knowledge of trouble shooting and problem-solving skills, as well as formal root cause analysis methods and tools.
* Bachelor's degree in a Scientific or Engineering related discipline
* Experience in a Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing in a FDA/ EU regulated environment
This role offers the opportunity to work on various projects, develop new skills, and contribute to the growth of our organization. If you are passionate about Quality Assurance and eager to take on new challenges, we encourage you to apply.