- ThermoFisher Scientific (Fremont, CA)
- …adhered to standard operating procedures (SOP) and current good manufacturing practices ( cGMP ) with the highest level of quality and compliance in a safe ... and timely manner that will meet customer expectations. Works with team members and biologicals to manufacture or qualify material for IVD use. Participates and/or lead in process improvement projects. **Key Responsibilities:** + Manufacture particle products,… more
- Element Materials Technology (Concord, CA)
- …+ Requires advance knowledge and hands-on experience in QA and cGMP . + Self-motivated, proactive individual with strong interpersonal skills, excellent oral ... and written and communication skills, strong computer skills and customer service. Ability to work as a team member. + Effective people leader. Nurture employee potential through coaching, mentoring, and training. Provide guidance, set clear goals, provide… more
- Medtronic (Los Angeles, CA)
- …understand schematics and engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable skills in Microsoft Office products as well ... as ERP and CRM software packages (such as SAP, ServiceMax and SalesForce.com) + Excellent analytical and communication skills with the ability to communicate complex technical issues in an easy to understand manner, are necessary to accomplish this task +… more
- CSL Plasma (Stockton, CA)
- …internal audits to monitor facility compliance with CSL procedures and policies, cGMP , OHSA, FDA, and other regulations, as applicable, and develop center responses ... for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. + Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate… more
- Kelly Services (Sacramento, CA)
- …manufacturing of pharmaceutical products. This includes ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements ... (eg, FDA, EMA, MHRA). The QA Manager will lead a team in managing quality systems such as deviations, CAPAs, change control, batch release, validation oversight, and audit readiness. The role requires close collaboration with production, QC, regulatory… more
- Catalent Pharma Solutions (San Diego, CA)
- …project success while complying with regulatory requirements, good manufacturing practices ( cGMP ) and standard operating procedures (SOPs). The focus will be on ... understanding client needs and providing excellent customer service and proactive solutions. Primary responsibilities of this position include activities related to supply chain, procurement, batch record and label creation, and other project management and… more
- Terumo Neuro (Aliso Viejo, CA)
- …and validate manufacturing processes of medical devices and working knowledge of cGMP . 4. Knowledge of statistical tools including Design of Experiments (DOE) and ... experience with improving existing process capabilities and optimization. 5. Expertise in process design, optimization, and validation (IQ, OQ, PQ). 6. Proficiency with statistical tools (eg, Minitab). 7. Hands-on experience with manufacturing processes… more
- Terumo Neuro (Aliso Viejo, CA)
- …and validate manufacturing processes of medical devices and working knowledge of cGMP . 4. Knowledge of statistical tools including Design of Experiments (DOE) and ... Cpk for process development, characterization, and optimization preferred. 5. Knowledge of process design, optimization and validation (IQ, OQ, PQ). 6. Familiarity with statistical tools (eg, Minitab). 7. Proven knowledge of Lean/Six Sigma techniques (Green or… more
- Mentor Technical Group (Millbrae, CA)
- …and Environmental. High familiarity with OSHA, DOT and EPA regulations and cGMP procedures. + Thorough understanding of EHS procedures; analytical and problem ... solving skills; supervisory skills and experience; strong communication skills (speaking and listening); knowledge of EHS regulation and best practices; technical writing; conflict resolution skills; computer literate; team building skills; a desire to develop… more
- VTI Life Sciences (San Diego, CA)
- …execution, and reporting is a plus. + Previous experience in a cGMP /FDA-regulated manufacturing environment is a plus. + Must be proficient with/ Microsoft ... Office, including Word, Excel, PowerPoint, etc. + Must have technical writing, review, and analytical skills in addition to strong verbal communication and presentation skills + Must have a strong ability to organize and manage multiple tasks in a fast-paced… more