Collecting information
Organizing data
Provides continuous availability for medical and technical questions to our client patients, our patient care staff, and ancillary care providers.. Adheres to privacy, compliance, and quality programs and other regulatory and compliance standards of the Practice and the Crossover Medical Group.. Completion of an ACGME approved Residency in Family Medicine or Internal Medicine. Current Certification or active participation in the exam process leading to certification by a Family Medicine or Internal Medicine Specialty Board.. Knowledge of and experience with managed healthcare systems including, quality assurance, quality improvement, risk management, and population health and disease management programs
White Blossom Care Center is seeking a dedicated and passionate Physical Therapist to join our team full-time.. Variety of cases including ortho, neuro, cardio & vascular etc.. Modalities on site for pain management, Estim, Ultrasound, Diathermy, PAM certification opportunities for OTs. Ensure high standards of patient care, focusing on short-term rehabilitation for Medicare patients.. Uphold the values of White Blossom Care Center by prioritizing patient safety, dignity, and comfort in every aspect of care.
Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases.. Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine.. BSc in natural or health sciences (biology, pharmaceutical sciences, or equivalent).. Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.. Join us in our quest to reimagine cell therapy and destroy cancer.
Process and Organizational Effectiveness.. Take personal responsibility for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects. At least three-year experience working in a medical device manufacturing company, preferably with capital medical equipment, highly desired. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. Provide regulatory advice and information to cross-functional teams and to other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals. A degree in a life science or closely related discipline with a higher degree preferred (e.g., MSc, MPH, PhD, PharmD). A minimum of 15 years direct pharmaceutical regulatory affairs, including 5 years of International Regulatory experience is required. Experience in a small company and hands-on marketing application experience from preparation through submission and approval in a non-oncology, rare disease indication is strongly preferred in regions including, but not limited to EU, APAC, and LATAM.
Perform data review supported by Clinical Research Scientist(s) (CRS), participate in protocol deviation meeting that will occur monthly or as needed.. Create or support the creation of relevant clinical documents of high quality, such as study protocol protocol(s), investigator brochure (IB), informed consent forms (ICF), case report forms (CRF), Clinical study report (CSR), NDA/MAA registration documents, and scientific publications.. Successful completion of MD training mandatory; 3 years of clinical experience in treating oncology patients or a completed fellowship in a Hematology-Oncology program.. 8 years of combined experience in oncology clinical research and drug development in academic and/or industry, including experience as a medical monitor and (sub)investigator in oncology clinical trials.. 3 years in industry leadership as medical lead for an oncology development program(s) with direct or indirect management of cross-functional areas (e.g., clinical operations, biostatistics, data management, biomarker, pharmacovigilance, quality, etc.)
Perform data review supported by Clinical Research Scientist(s) (CRS), participate in protocol deviation meeting that will occur monthly or as needed.. Create or support the creation of relevant clinical documents of high quality, such as study protocol protocol(s), investigator brochure (IB), informed consent forms (ICF), case report forms (CRF), Clinical study report (CSR), NDA/MAA registration documents, and scientific publications.. Successful completion of MD training mandatory; 3 years of clinical experience in treating oncology patients or a completed fellowship in a Hematology-Oncology program.. 8 years of combined experience in oncology clinical research and drug development in academic and/or industry, including experience as a medical monitor and (sub)investigator in oncology clinical trials.. 3 years in industry leadership as medical lead for an oncology development program(s) with direct or indirect management of cross-functional areas (e.g., clinical operations, biostatistics, data management, biomarker, pharmacovigilance, quality, etc.)
The Associate Director of CMC Regulatory Affairs provides support for all CMC regulatory activities related to the ongoing development, registration, and life-cycle management of RYTELO (imetelstat) and other potential future development product candidates. The position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Associate Director reports to the Senior Director, CMC Regulatory Affairs. Support other US/EU/labeling and operations groups within global Regulatory Affairs on behalf of CMC regulatory as needed.. Provide review and input on updates to CMC regulatory documents (e.g., QOS/Module 3) for submission to regional regulatory agencies and contribute to preparation of registration dossiers (e.g., NDA and MAA).. Breadth of global CMC regulatory affairs experience in drug development and for commercialized products is required with a good all-round understanding of Module 3 content and requirements
This includes the Frank Residences, offering luxurious assisted living and memory care services; the Jewish Home and Rehabilitation Center, featuring long-term skilled nursing, short-term rehabilitation, and an acute psychiatric unit specialized in mental healthcare for older adults over age 55; and the Jewish Home and Senior Living Foundation. Grounded in the Jewish values of dignity, compassion, and community, the San Francisco Campus for Jewish Living, fondly referred to in the past as "the Jewish Home," was founded in 1871. Knowledge of community mental health systems, legal requirements under the Lanterman-Petris-Short (LPS) Act, and discharge planning for high-risk psychiatric patients. Associate Director, GMP Quality Assurance San Francisco, CA $180,000.00-$195,000.00 2 weeks ago.. Executive Director GCP Quality Assurance Hercules, CA $199,400.00-$274,100.00 2 weeks ago
Lead the development and review of key documents, including statistical analysis plans, clinical study reports, and regulatory filings (e.g., NDA, BLA, MAA).. Ensure compliance with industry and regulatory standards, including ICH, GCP, FDA, EMA, and CDISC.. Strong knowledge of statistical methods for clinical trials, regulatory guidelines, and CDISC standards (SDTM, ADaM).. Director of Finance and Administration, Biomedical Data Science. Director, Early Clinical Development (MD), Autoimmune Cell Therapy
The technologist is licensed in all scopes of practice as defined by the State of California Radiologic Health branch, and performs routine to complex diagnostic and therapeutic nuclear medicine procedures using radiopharmaceuticals to assist in diagnosis and/or treatment in both the inpatient and outpatient environment.. Responsible for performing radiation safety and quality control procedures on all Nuclear Medicine equipment as required by the department.. Oversee advanced nuclear medicine fusion imaging procedures to ensure diagnostic precision and optimal patient care.. Possession of a valid Nuclear Medicine Technologist certification and state licensure is required.. Extensive experience with fusion imaging modalities, including PET/CT and SPECT/CT, is preferred.
Contribute in the documentation of quality systems and programs in the areas of training, change management, validation, design controls, including product verification and validation, CAPA for relevant design issues, documentation control considerations, etc.. Must have exposure to and knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, MDSAP, etc. One or more of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.. Software Quality Engineer- Medical Device Mountain View, CA $64.00-$75.00 3 weeks ago. Software Quality Engineer/Senior Software Quality Engineer- Medical Device Sunnyvale, CA $95,000.00-$130,000.00 2 weeks ago
Software Quality Engineer/Senior Software Quality Engineer- Medical Device Sunnyvale. This role will also assist on maintaining quality systems, supporting Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCR), complaints, audits, and overall Quality Management System (QMS) functions.. Participate in design control activities to ensure software quality throughout the product lifecycle, including planning, development, testing, and post-market surveillance.. Bachelor’s degree in Computer Science, Biomedical Engineering, Electrical Engineering, Quality Engineering, or a related technical field (Master’s preferred), or equivalent experience.. Certification in quality management or software quality (e.g., ASQ, CMMI) is a plus.
Medical Writer, QC Specialist About Artos Artos is revolutionizing regulatory document creation with AI. We work with leading life sciences companies to streamline medical writing and submission processes, ensuring accuracy, efficiency, and compliance.. The Role We are looking for a Medical Writer with a Quality Control (QC) specialization to help ensure the accuracy, clarity, and compliance of the documents produced by our AI-powered platform.. Review and QC regulatory documents (e.g., clinical study reports, investigator brochures, protocols, IND/CTA/NDA/BLA submissions) generated by our AI platform during product development.. Ensure accuracy, clarity, and compliance with regulatory guidelines (ICH, FDA, EMA) and internal style guides.. Collaborate with a team of experts in medical writing, AI, and regulatory affairs.
The Compliance Analyst I (CA I) is a compliance professional who supports the agency's compliance program under the direction of the Compliance Manager.. Audit and Investigation Support: Assist in preparing for external audits, surveys, and investigations by gathering documentation, organizing records, and participating in on-site "command center" support during audit visits.. Data Review and Analysis: Regularly review and analyze data from the EHR and other compliance tracking systems to identify patterns or red flags (e.g., documentation errors, incident trends).. Medical Records Retrieval: Provides support in processing Medical Records for general requests, subpoenas, court orders or similar requests as vetted and directed by Compliance management.. Regulatory Compliance Specialist - Los Angeles, CA Contracts Manager - Contracts, Compliance, Procurement Associate General Counsel, Sanctions Compliance Compton, CA $70,000.00-$80,000.00 2 weeks ago
Kforce has an enterprise client that is seeking a Quality Assurance Tech in Sunnyvale, CA. We are seeking a talented and highly motivated Quality Assurance Engineer (QAE) for a contract position. Experience with HTML, JavaScript, Java and SQL is desired but not required.. The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees.
Produce Facility Monitoring reports, Unannounced Visit reports, Quality Assurance Reviews, Corrective Action Plans, Immediate Danger Reports, Sanctions, and correspondence, and file material as needed.. Coordinate with SARC case management, SARC BCBA team, SARC Health Services Unit to arrange and facilitate EBSH, CCH, and ARFPSHN Quality Assurance Reviews.. Coordinate with DDS and lead any reviews with DDS for EBSH/CCH and FHA. Attend and provide support for relevant meetings, including Mortality, Let’s Talk, Quality Assurance Advisory, Residential and Day program round table, etc.. Standards Compliance Coordinator
Minimum of 3-5 years practical experience in a quality, laboratory or cGMP regulated production environment in 21 CFR regulated industries (i.e., food, dietary supplements, personal care, medical devices, etc.. Familiarity / knowledge of cGMPs, HACCP/food safety, laboratory safety, GFSI/SQF, ISO, National Organic Program and Kosher guidelines a plus. An innovative leader in the organic food industry, Nutiva (www. nutiva.com) is the world's best-selling brand of organic coconut, hemp, chia and redpalm superfoods. We donate 1% of sales to support sustainable agriculture.
Perform visual and dimensional/mechanical inspection of raw materials such as, machined parts, optics, chassis, assemblies, packaging materials (labels, software, product inserts, optics, etc. Follow BDIS Environmental, Health and Safety (EH&S) policies and procedures. Computer literate with basic knowledge or Microsoft Windows & Office, SAP, Minitab, etc. Staff Software Quality Assurance Engineer Quality Assurance Quality Control Engineer Commercial Kitchen Equipment and Refrigeration Technician San Francisco Bay Area $130,000.00-$165,000.00 2 weeks ago.. Process Validation Engineer (Manufacturing Processes and QC Test Methods) Technician II Quality Control - First Shift We’re unlocking community knowledge in a new way.
Experience with biologics, tissue/organ or cord blood/stem cells or equivalent. Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS. Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities. Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema. Traumatic brain injury