- Hologic (San Diego, CA)
- …systems and process engineering + Biotech / Medical Device / Pharmaceutical industry experience + Thorough knowledge of manufacturing automation systems and best ... related to water systems. + Participate and provide guidance in validation activities, including protocol development, execution, and report generation. + Identify… more
- Charles River Laboratories (Northridge, CA)
- …the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and ... Manage the inspection/back room during regulatory or customer audits. * Review validation reports (IQ/OQ/PQ) * Manage or support the Quarterly Management Review… more
- Gilead Sciences, Inc. (Foster City, CA)
- …candidate is expected to serve as the CMC analytical lead on PDM ( Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career ... identify molecule CQAs, design/justify/execute end-to-end control strategies, support CMC process development, issue CoTs, seek Specfication endorsement, and author… more
- J&J Family of Companies (Santa Clara, CA)
- …Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This ... or complexities for programming activities. + Perform quality control (QC) and validation of internally and externally developed datasets and outputs, adhering to… more
- Terumo Neuro (Aliso Viejo, CA)
- …such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans. + Review ... all data management activities to ensure consistency of clinical data process across studies. + Work collaboratively with biostatistics, programming and other… more
- Edwards Lifesciences (Los Angeles, CA)
- …the TMTT Biostatistics department on all aspects of the clinical development process , ranging from clinical trial designs to regulatory submissions while applying ... study reports and other documents, and provide programming and validation support of these analyses + Statistical lead on...guidelines (eg, GCP, ICH, FDA, ISO) relevant to in Pharmaceutical /Medical Device research setting + Proven expertise in SAS… more
- Cushman & Wakefield (Irvine, CA)
- …Science projects and will be expected to be versed in pharmaceutical construction and qualification. Must have exceptional organizational, analytical and ... Science projects and will be expected to be versed in pharmaceutical construction and qualification. Must have exceptional organizational, analytical and… more
- Teledyne (Hawthorne, CA)
- …research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research. We are looking for individuals who thrive on making an ... with LabView, python, or similar test and automation software. + Generate validation test plans to ensure products meet specified requirements. + Recommend changes… more
- Norstella (Sacramento, CA)
- …MMIT joined forces with other market-leading pharmaceutical -solutions providers-Evaluate, (https://www.evaluate.com/) Citeline, Panalgo (https://panalgo.com/) andThe ... understanding of knowledge, data, and product to resolve data validation requests in accordance with MMIT standards and client...as part of a team + Knowledge of the pharmaceutical and managed care industries - 1-2 years experience… more
- US Tech Solutions (Irvine, CA)
- …reports including but not limited to Microbiology and Analytical data, method validation , stability and technical reports. * Draft technical documents including but ... and documentation that are produced in CMC during clinical development of pharmaceutical and biological drugs (eg manufacturing and QC of clinical trial material,… more
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