6 jobs found

Alkermes, Inc. POSITION SUMMARY The QC Microbiology Analyst I/II 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. MAJOR RESPONSIBILITIES Major Responsibility Percentage of time spent on each responsibility 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 40% Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden) 35% Enumerate organisms on cultured media for environmental monitoring and utility samples. 15% Review of routine paperwork 5% Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab...

The MetroHealth System Location: METROHEALTH MEDICAL CENTER Biweekly Hours: 80.00 Shift: 7:30a- 4p Monday-Friday; Available for call after hours The MetroHealth System is redefining health care by going beyond medical treatment to improve the foundations of community health and well-being: affordable housing, a cleaner environment, economic opportunity and access to fresh food, convenient transportation, legal help and other services. The system strives to become as good at preventing disease as it is at treating it. Founded in 1837, Cuyahoga County's safety-net health system operates four hospitals, four emergency departments and more than 20 health centers. Summary: Provides strategic and operational leadership and serves as a contact for senior leadership on biomedical technology issues for the MetroHealth System and related entities. Direct activities of the Clinical Engineering department and Health Technologies management in selecting, procuring, and...

Alkermes, Inc. Overview: The Quality Control Supervisor oversees the daily operations of a group of analysts, sets clear objectives around the execution and delivery of the QC work load. The Supervisor works cross-functionally with QC management and leaders of other departments to support the commercial release of raw materials and finished products. The supervisor also ensures that all activities within the laboratory are performed in compliance with cGMP and internal written procedures and policies. The supervisor is responsible for scheduling personnel and material resources to ensure that testing commitments are satisfied and communicate any difficulties to QC management. The supervisor is accountable for the accuracy, integrity, and security of all results generated by the working group. The supervisor Measures progress, evaluates results, and takes responsibility for outcomes. Responsibilities: Supervise testing to ensure compliance with all applicable procedures, and...

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,...