Quality Assurance Specialist Job Overview
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes.
Job Description:
The Quality Assurance Specialist will be responsible for overseeing all validation activities to ensure compliance with current regulatory requirements, cGMP, and company SOPs. This includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping.
* Ensure the quality oversight of the qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping processes.
* Review and approve all validation documentation and associated data, including plans, URSs, quality risk assessments, protocols, and reports, for conformance to SOPs, specifications, and other applicable acceptance criteria.
* Provide QA oversight, review, and approval for events/deviations, investigations, and change evaluations that occur during qualification/validation activities in accordance with SOPs and cGMP requirements.
Required Skills and Qualifications:
To be successful in this role, you will need:
* Deep knowledge of GxP regulations applicable to biologics manufacturing (e.g. EU-GMP, FDA, ISO) and industry standards applicable to validation (e.g. GAMP, ISPE, ISO, ASME, BPE).
* Troubleshooting and problem-solving skills.
* Familiarity with formal root cause analysis methods and tools (e.g. Ishikawa diagrams, FMEA).
Benefits:
This is an excellent opportunity to join a dynamic team and contribute to the success of our organization. You will have the chance to work on challenging projects, develop your skills, and grow your career.
Others:
We offer a competitive salary and benefits package, as well as opportunities for professional development and advancement.