4 controller jobs found

Kaiser Permanente Job Summary: The Research Coordinator will provide research coordination and project management for the Health System Science (HSS) department within the Kaiser Permanente Bernard J. Tyson School of Medicine under the guidance of the Director of HSS Research Operations. The KPSOM HSS department mission includes: 1) the pursuit of a broad scholarship agenda that will improve population health and health care through systems transformation and redesign; and 2) delivery of an innovative foundational curriculum in four domains: community and population health, health care and social systems, quality and safety, and research methods to inform evidence-based clinical practice. This position will support a randomized controlled trial that will test whether telephone-based care coordination through 211 LA increases referral to and receipt of Adverse Childhood Experiences (ACEs)-related services for children ages 0-11 years and improves parent and child wellbeing...

Alkermes, Inc. POSITION SUMMARY The QC Team Lead will join the microbiology group to provide technical supervision, coordinate and track projects, act as point person on CMC Teams and validation projects. Responsibilities will also include reviewing, reporting test results as related to validation protocols. Direct Support for Method development and optimization for all Microbiology methodology and testing such as Endotoxin, Sterility, Biological Indicators, Microbial Limits, Bioburden. Suggest and implement new technologies and equipment for Microbiological testing. QUALIFICATIONS A four year degree in science, preferably in Biology or Microbiology with minimum 8 years' experience in the pharmaceutical industry Experience with the execution of test methods for sterile and non-sterile drugs, raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters Critical thinker,...

Alkermes, Inc. Temp QC Analyst-EM POSITION SUMMARY The QC Microbiology Analyst will be responsible for performing functions including environmental monitoring, utilities monitoring, and testing in a facility that manufactures sterile products and tablets in a GMP environment. REPSONSIBILITIES Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manufacturing schedule will be required, which may include over time, weekend or shift work, and holidays Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden) Enumerate organisms on cultured media for environmental monitoring and utility samples. Review of routine paperwork Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab cleans etc. QUALIFICATIONS Ability to work hard and contribute to an enjoyable working environment...

Alkermes, Inc. The Manager position within Clinical Supply Chain leads end-to-end supply chain management on single to multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. They work closely as a key point of contact with Clinical Operations, Regulatory Affairs, Quality, Internal & External Manufacturing, and other Clinical Supply Chain personnel leading supply activities for complex programs that may require multinational interactions. In addition, they coordinate and lead supply activities with both internal and external partners. The successful candidate will thrive in a highly collaborative team environment to ensure the successful development of new drugs. Responsibilities Review clinical trial protocols and understand impact on supply Partner with Clinical Operations to identify demand assumptions and review enrollment plans and actuals for use in developing the supply requirements plans Create, review, and update...