- Actalent (Alameda, CA)
- …the execution of equipment and process IQ/OQ/PQ. + Ensure compliance with FDA regulations and the company's quality requirements in manufacturing processes. + Manage ... equipment maintenance, repair, and calibration services to keep production equipment operational. + Conduct studies and tests to support research, design, and development of components, parts, or changes for new or existing products. Essential Skills +… more
- Norstella (Sacramento, CA)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient,… more
- Pfizer (South San Francisco, CA)
- …field with 7+ years of experience in clinical trials. High aptitude in: * FDA /EMA and other regulations * ICH GCP guidelines * Drug development process * CDISC ... standards and implementation guides * Statistical methods and applications to clinical trial design and data analysis * Programming skills in R and/or SAS * Company SOPs and business practices * Demonstrated ability to: * Develop and deliver multi-mode… more
- Dreisbach Enterprises (Richmond, CA)
- …documentation, forms, emails, and work schedules + Ensure compliance with OSHA and FDA standards by adhering to developed sanitation methods and procedures + Assist ... in the development and implementation of Sanitation Standard Operating Procedures (SSOP) + Perform audits of the sanitation process to monitor for compliance to the Good Manufacturing Practice (GMP) standards with regards to sanitary controls Requirements +… more
- BrightSpring Health Services (San Diego, CA)
- …therapy guidelines, medication safety practices, and regulatory standards (CMS, DEA, FDA ). + Proficiency in electronic medical records and pharmacy information ... systems + Strong clinical judgement, and effective written and verbal communication + *Position will be posted for a minimum of 7 business day About our Line of Business PharMerica, an affiliate of BrightSpring Health Services, delivers personalized pharmacy… more
- BeOne Medicines (Emeryville, CA)
- …Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines. + Experience in writing clinical sections of INDs, ... MAAs, and NDAs is a plus. + The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents. + Working knowledge of drug/biologics development, clinical research, study design, biostatistics,… more
- Astrix Technology (Los Angeles, CA)
- …ensure all materials meet creative excellence and regulatory standards, including FDA and claims compliance where applicable. + Drive experimentation with emerging ... formats, platforms, and interactive content, with an emphasis on short-form video. _Team & Cross-Functional Collaboration_ + Partner closely with Marketing, Creative, Scientific Affairs, Research, Product Development, and Sales teams to ensure cohesive,… more
- ZOLL Medical Corporation (Stanford, CA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more
- University of Southern California (Los Angeles, CA)
- …+ Collects documents needed to initiate study and submit to sponsor (ie, FDA Forms, CVs, etc) + Assists in the informed consent process, including interactions ... with the IRB and discussions with research participants, including answering any questions related to the study. Assures that amended consent forms are appropriately implemented and signed. + Screens subjects for eligibility using protocol-specific inclusion… more
- Aerotek (San Diego, CA)
- …manufacturing or pharmaceutical environments preferred. + Familiarity with GDP, GMP, GLP, FDA , and ISO standards. + Knowledge of qualification and validation trials ... is a plus. + Working knowledge of Microsoft Office and large Enterprise Resource Planning (ERP) systems preferred. **Why Work Here?** The team invests in each employee's growth and success. As a part of the team, even contractors are invited to participate in… more