Job Title: Quality Assurance Specialist
The Quality Assurance Specialist plays a crucial role in ensuring compliance with current regulatory requirements, cGMP, and company SOPs.
This includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning processes, storage areas, controlled temperature units (CTUs), and shipping.
Main Responsibilities:
* Ensure the quality oversight of qualification/validation activities
* Review and approve validation documentation and associated data
* Provide QA oversight to Commissioning, Qualification, and Validation (CQV) activities
Requirements:
* Bachelor of Science or Bachelor of Engineering degree in a scientific or engineering-related discipline
* 4-5 years experience in Quality Engineering/Quality Assurance/Quality Validations role
* Deep knowledge of GxP regulations applicable to biologics manufacturing
About this Role
This position is responsible for ensuring that all quality-related activities are conducted in accordance with established procedures and standards.
The ideal candidate will have strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills.
We offer a competitive salary and benefits package to successful applicants.
Key Skills and Qualifications
* Strong understanding of quality management principles and practices
* Ability to analyze data and make informed decisions
* Excellent written and verbal communication skills
* Strong organizational and time management skills