- Boehringer Ingelheim (Fremont, CA)
- …to proper technique, proper documentation practices, and all other aspects of the cGMP 's + Must maintain all training requirements and regularly checks the LOS ... training system in order to complete all required training on time. **Desired Skills, Experience and Abilities** + Experience with manufacturing execution systems (electronic batch records). Experience working in multiple projects. + minimum of one year MBR… more
- Amgen (Thousand Oaks, CA)
- …engineers, including selection, on-boarding, assigning training and managing according to cGMP procedures and requirements and existing Amgen products and platforms ... + Support development of characterization methods for mechanical and physical properties of primary components + Support ongoing Nonconformance/CAPA and Change Control + Collaborate extensively with internal and external team members, ie manufacturing,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …commercialization of combination products. + Working knowledge of FDA, EMA, and cGMP standards for combination products. + Strong verbal, written, and interpersonal ... communication skills. + Able to write clear, concise, and error-free documents. + Able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action. **People Leader Accountabilities:** +… more
- Hologic (San Diego, CA)
- …+ Proficient knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation, cGMP , CFR 820, ISO-13485, ISO-14971, ISO-9001 + Experience with PPAP (plus) ... **Skills:** + Expertise in various validation methods and evaluation criteria + Advanced understanding of process transfer, materials control, change control, manufacturing processes, and product testing + Proficient in interpreting engineering drawings and… more
- Herbalife (Torrance, CA)
- …interpretation. + Ensure all work complies with current Good Manufacturing Practices ( cGMP ) and Good Documentation Practices (GDP). + Contribute to audit readiness ... and documentation accuracy. + Draft scientific publications, validation protocols, and technical reports. + Represent the company at conferences and in industry working groups (eg, AOAC, USP, multi-lab studies). + Propose projects that align with the business… more
- Terumo Neuro (Aliso Viejo, CA)
- …field. 2. Design and development of medical devices and working knowledge of cGMP . 3. Ability to read and prepare technical documentation. 4. Working knowledge of ... standard machine shop equipment, processes, and medical device manufacturing equipment. 5. Knowledge of medical and technical development as well as international regulations for medical devices. 6. Minimum one (1) year of manufacturing experience preferred.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and strategic input. + Provide technical support to internal and external cGMP manufacturing operations. + Presents research findings and recommendations to senior ... staff, prepare research reports and peer-reviewed manuscripts, and contribute to the preparation of INDs, and patent filings. **Basic Qualifications:** Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR Ph.D.… more
- Curia (Camarillo, CA)
- …combination of education and experience Preferred + Experience working in cGMP or GLP pharmaceutical industry environment Knowledge, skills and abilities + ... Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public + Ability to meet deadlines and work under pressure with… more
- Curia (Camarillo, CA)
- …+ Complete tasks as required (in a timely manner), compliant with cGMP , regulatory and corporate requirements and conform to Health, Safety & Environmental ... responsibilities. + Mentor chemists and analysts + Write, review, revise and approve: + Standard Operating Procedures (ie Laboratory Procedures) + Project Progress Reports + Project Timelines + Acceptance Methods + Test Data (Summary Results) + Conduct and… more
- Herbalife (Torrance, CA)
- …and practical experience in product/process development and maintenance in a cGMP environment. + Proficient with utilizing statistical tools for product/process ... improvement and develop robust formula specifications. + Proven track record to learn with an open mind and adapt to new technologies and methodologies quickly. + Ability to prioritize and execute appropriate project plans and implement them with limited to no… more