2 controller jobs found in Wilmington

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...