Job Title: Quality Assurance Specialist II
Department: Quality Assurance
Category: Quality and Regulatory
Job Summary:
We are seeking a Quality Assurance Specialist II to join our client's innovative biotechnology company. This intermediate-level position offers hands-on experience in quality systems, reserve sample programs, and incoming attribute inspections. You'll work cross-functionally with teams such as Quality Control, Manufacturing, and Regulatory Affairs to ensure compliance with applicable US and international regulations for biologic drug substances and products under clinical development.
Key Responsibilities:
- Perform a variety of QA activities to ensure compliance with procedures and regulatory requirements.
- Manage reserve sample programs and perform incoming quality attribute inspections.
- Review and track closure of change controls, deviations, quality investigations, and CAPAs.
- Prepare quality system metrics and review incoming raw materials.
- Support quality operations, including batch record and quality control data review, line clearances, and product inspections.
- Contribute to continuous improvement of quality systems and assist in compliance audits.
- Provide inspection readiness support for regulatory inspections.
Experience & Skills Required:
- 4+ years of experience in quality functions within pharmaceutical or biotech industries.
- Working knowledge of cGMP standards for clinical biologics.
- Ability to manage multiple tasks in a fast-paced environment and work independently with moderate supervision.
- Strong verbal, written communication, and interpersonal skills.
- Proficient in CAPA, cGMP, batch records, and quality systems.
Education:
- Bachelor's degree in biology, chemistry, or a related field (or equivalent experience).
This is a fantastic opportunity for candidates looking to further their careers in Quality Assurance within a dynamic and growing industry. Apply now to make an impact!
