2 manufacturing jobs found

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. GENERAL DESCRIPTION: The position requires the individual to perform routine/non-routine physical, chemical, and in-vitro assays of clinical, commercial, process and cleaning validation samples, and process development samples to support Manufacturing. Performs physical and/or chemical analyses of product to ensure stability. Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. KEY DUTIES: Perform and record analyses as assigned on a daily basis. Adhere to cGMP's in all work practices. Assist in maintaining a clean, safe workplace on a daily basis. Review peer's work as needed. Review and revise test methods. Write and disseminate technical data summaries and reports as needed. Research and recommend...