4 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. GENERAL DESCRIPTION: The QC Analyst I performs testing of samples submitted to the laboratory in a cGMP compliant manner, as well as according to approved written procedures. The QC Analyst I may be required to write or revise SOPs, analytical procedures, or other analytical documentation at the discretion of quality control supervisory staff. KEY DUTIES: Perform testing in accordance with written procedures Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices. Processing of electronic data using procedures that ensure data integrity and security. Ship samples to contract testing facilities. Entry of test results from contract laboratories Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations....

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...