Temp-QC Analyst EM-1st Shift

AlkermesWilmington, OH
12d

About The Position

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.

Requirements

  • Ability to work hard and contribute to an enjoyable working environment
  • Ability to work safely; seek out and encourage safe practices
  • Gowning in an aseptic environment
  • Self-starter that takes initiative to perform work with minimal supervision
  • Maintain documentation in accordance with GMP including timely recording of information
  • Ability to cope with a rapidly changing work environment
  • Maintains a clean, organized lab environment
  • Commitment to teamwork
  • Willingness to learn new things
  • Commitment to continuous improvement in all areas
  • Effective communication with co-workers and supervisors
  • Pays attention to detail and ensures high quality work
  • EDUCATION: High School diploma, Associate or Bachelor Degree in a biological science.
  • EXPERIENCE: High School diploma with some experience in a GMP lab environment or Bachelor or Associate Degree in a biological science. Some college education may be substituted with additional years of relevant work experience.

Responsibilities

  • 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.
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