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
...Shared Living Providers (SLPs) at Nexus are independent contractors who offer residential support in their own homes for individuals with developmental disabilities. If you're seeking a fulfilling career where you can contribute to positive outcomes for others, our Shared...
...dedicated individuals, who align with these values, to join our team at various locations across the globe. Job Summary Ramp agents provide all necessary and required under-wing ground support services as contracted by the customer, including, but not limited...
...protect your peace of mind and patient safety with a consistent 1:3 pharmacist-to-technician ratio . Manageable Pace: Forget the stress... ...analytical problem solving and collection of information, and research data. Ability to communicate effectively verbally and in...
...Summer Sales Internship Dallas, TX | Summer 2026 | Uncapped Earnings This is not a typical internship. Persona Directs Summer Sales Internship is a high-performance opportunity for driven students who want to earn serious income, develop elite sales skills,...
...Job Description Job Description This role is ideal for caretakers and teachers at heart. Shared Living Providers (SLP) share their home and life experiences while providing habilitative services. Habilitation services provided will vary, based on the assessed needs...