Tech 3, Microbiology Development

Must be onsite
-M-F 40 hrs a week.; we are flexible with start times and staff start anywhere from about 7:30 am - 9 am
-Interviews process: in person preferred. can do video if needed.
-Extension is possible
-We are needing someone who has a an understanding of micro lab testing/techniques that can get up and running quickly to preform compendial micro testing.

Skillset Matrix

Manager Notes

Technology Requirements (I.E Programs, systems, etc)

comfortable using microsoft suite tools

What does a typical day look like? (daily tasks)

micro testing assigned by area supervisor a week before hand. Weekly tasks can include, bioburden, endotoxin, BI, microbial limits or Environmental testing, plate reads and general test set up and lab 5s cleanup.

Preferred background/prior work experience?

prior micro lab experince preferred.

Priority soft skills

micro testing and EM troubleshooting ability, highspeed manufacturing environment, cleanroom environment.

Job Summary:

Supports the Quality Assurance Laboratory by performing a variety of tests as part of product release and
the sterilization assurance program. As assigned, performs environment monitoring in classified GMP
manufacturing areas, executes protocols in an EO sterilizer staging area and tests for organisms in a lab
or cleanroom setting. Supports these activities with appropriate documentation following GDP.

Job Responsibilities:

(Primary Duties, Roles, and/or Authorities)
1. Maintains the cleanliness and orderliness of laboratory glassware.
2. Performs verification of lab equipment.
3. Maintains and distributes chemicals and supplies.
4. Maintains materials inventory.
5. Conducts monthly inspections of laboratory safety equipment.
6. Complies with regulations as outlined in GMPs.
7. Disposes of laboratory waste.
8. Aseptically and safely works with live organisms and cultures
9. Performs basic microbiological testing on raw materials and finished goods to ensure compliance
to specifications.
10. Works inside varying ISO classifications of clean rooms, including those with active manufacturing,
to perform testing
11. Perform routine analysis of EO/ECH residual testing of terminally sterilized medical using gas
chromatography (GC-FID).
12. Conducts investigations in a timely manner.
13. Writes technical reports.
14. Writes and updates standard operating procedures and laboratory documents/forms.
15. Work overtime as needed by the department. Work flexible hours as business needs require.
16. Communicate in an effective, timely, and appropriate manner to all associates (i.e. peers, support
teams and management) including escalating issues.
17. Comply with all local, state, federal, and Client safety regulations, policies, and procedures including
RCRA Hazardous Waste regulations.
18. Comply with all local Client quality policies, procedures, and practices through consistent application
of sound quality assurance principles.
19. Other duties as assigned.

* This is not intended to be an all-inclusive listing of duties. Other job-related duties may be required.

Education and Experience:

This position requires:
1. Two years relevant experience working in a laboratory environment or equivalent experience
2.

Experience with ISO and USP standards
3. Understanding of GLP, GMP, and GDP
Preferred qualifications include:
1. BS Degree in Microbiology/related STEM Degree
2. Knowledge of basic Microbiological or EO Sterilization terminology
3. Pharmaceutical and/or Medical Device experience
4. Experience in a manufacturing environment
5. Experience working with Bioburden BI s, PCD s, EO Residuals, Endotoxins and/or Environmental
monitoring and other Microbial related testing
6.

Experience with Labware, Empower and SAP

Knowledge and

Skills:

Critical Knowledge and Skill to perform and deliver to the scope and deliverables of the job.
1. Working knowledge of metric system
2. Ability to Interpret drawings and specifications
3. Effective written and oral communication skills (English), math skills, and interpersonal skills
4. Basic computer skills

Work Environment: (if applicable)
1. This position is in a clean room or laboratory manufacturing environment and the physical
demands described are representative of those that must be…