QC Microbiologist I, Environmental Monitoring

Location: Bedford, MA

Summary of Responsibilities:

The QC Microbiologist I, Environmental Monitoring will learn, understand, and perform routine entry level sampling of cleanrooms and utilities according to written procedures under cGMP conditions; as well as tasks involved with clerical and logistical laboratory tasks.

Specific Responsibilities:

  • Environmental Monitoring of ISO-5, ISO-7, and ISO-8 cleanrooms (contacts, viable airs, and total particulate sampling) in accordance with approved methods
  • Perform gowning qualification of personnel 
  • Utility sampling of RODI/WFI water systems (collect Bioburden and Endotoxin samples for testing) in accordance with approved methods
  • Train personnel on environmental monitoring
  • Prepare and host environmental monitoring meetings
  • Document all results in accordance with SOP
  • Report procedural deviations and nonconformances to management
  • Write and review investigations (Environment Control Notification, NCR, OOS, Planned Deviation) 
  • Preparing samples for outside vendor testing
  • Receiving and approval stickering of incoming microbiological media and reagents
  • Perform data entry, filing, and scanning of completed documents
  • Sterilization and cleaning of laboratory equipment
  • Sampling of incoming raw materials as needed (i.e. Sodium Hyaluronic Acid Powder)
  • Monitor room pressure readings in cleanrooms daily.
  • Participate in other projects as assigned

Job Complexity:

The position normally works on assignments routine in nature and receives detailed instructions on all work.  Responsible for supporting QC Laboratory working environment

Supervisory Responsibilities:

None

Experience, Knowledge, and Skills Required:

  • Associates or Bachelors Degree preferred or equivalent experience.
  • 1 – 2 years previous experience in a GMP laboratory desired; internship experience considered
  • ISO-5 (also known as Grade A or Class 100) Gowning experience
  • Ability to work flexible hours to complete work activities
  • Self-motivated with good time management and organizational skills
  • Good communication and writing skills
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We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

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