Quality Assurance Specialist

We are seeking a highly motivated and detail-oriented Quality Specialist to support key Quality Systems activities, including deviations/investigations, CAPAs, and change controls, within a regulated biotech and GMP‑controlled environment. This role plays a critical part in ensuring product quality, compliance, and continuous improvement across operations. Key Responsibilities: Lead and support investigations by gathering data, performing root‑cause analysis, and developing well‑structured, scientifically sound conclusions. Author, manage, and execute CAPAs to ensure effective and sustainable corrective and preventive measures. Initiate, assess, and manage change controls, ensuring changes are evaluated for regulatory, quality, and operational impact. Collaborate cross‑functionally with Manufacturing, Quality Control, Engineering, and other teams to drive timely resolution of quality issues. Prepare clear, accurate, and compliant documentation that meets internal standards as well as FDA, EU, and other global regulatory expectations. Ensure all quality records are completed within required timelines and maintained in an audit‑ready state. Support continuous improvement projects aimed at strengthening quality systems and operational efficiency. Qualifications: Experience working with GMP, biotech, or other regulated life‑science industries. Strong understanding of key quality system elements (deviations, investigations, CAPAs, change control). Excellent technical writing, documentation, and communication skills. Strong analytical and problem‑solving abilities with a high level of attention to detail. Ability to work independently, manage multiple priorities, and interact effectively with cross‑functional teams. This position is ideal for an individual who thrives in a quality‑focused environment, enjoys investigative problem‑solving, and is committed to maintaining the highest standards of compliance and accuracy. Seniority Level Associate Employment Type Contract Job Function Quality Assurance Industries Biotechnology Research and Pharmaceutical Manufacturing Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status, or disability status. #J-18808-Ljbffr Barrington James