QC Microbiologist I, Environmental Monitoring Position Available In Middlesex, Massachusetts
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Company:
Unclassified
Salary:
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Job Description
Job Description:
The QC Microbiologist I, Environmental Monitoring will learn,understand, and perform routine entry level sampling of cleanroomsand utilities according to written procedures under cGMPconditions; as well as tasks involved with clerical and logisticallaboratory tasks.
Specific Responsibilities:
- EnvironmentalMonitoring of ISO-5, ISO-7, and ISO-8 cleanrooms (contacts, viableairs, and total particulate sampling) in accordance with approvedmethods
- Perform gowning qualification of personnel
- Utilitysampling of
RODI/WFI
water systems (collect Bioburden and Endotoxinsamples for testing) in accordance with approved methods
- Trainpersonnel on environmental monitoring
- Prepare and hostenvironmental monitoring meetings
- Document all results inaccordance with SOP
- Report procedural deviations andnonconformances to management
- Write and review investigations(Environment Control Notification, NCR, OOS, Planned Deviation)
- Preparing samples for outside vendor testing
- Receiving andapproval stickering of incoming microbiological media and reagents
- Perform data entry, filing, and scanning of completed documents
- Sterilization and cleaning of laboratory equipment
- Sampling ofincoming raw materials as needed (i.e. Sodium Hyaluronic AcidPowder)
- Monitor room pressure readings in cleanrooms daily.
- Participate in other projects as assigned
Job Complexity:
Theposition normally works on assignments routine in nature andreceives detailed instructions on all work. Responsible forsupporting QC Laboratory working environment
Experience, Knowledge,and Skills Required:
- Associates or Bachelors Degree preferred orequivalent experience.
- 1 – 2 years previous experience in a GMPlaboratory desired; internship experience considered
- ISO-5 (alsoknown as Grade A or Class 100) Gowning experience
- Ability to workflexible hours to complete work activities
- Self-motivated withgood time management and organizational skills
- Good communicationand writing skills
