Tech 3, Microbiology Development

TechDigital Group; Sandy (UT); On-site; USD 42,000 - 65,000; Full time

Job summary

TechDigital Group is seeking support for the Quality Assurance Laboratory to perform tests for product release and sterilization assurance. The role involves environment monitoring in classified GMP areas, EO sterilization testing, and documenting results following GDP guidelines.

Two years of lab experience and knowledge of ISO/USP/GDP standards are preferred, with opportunities to work in cleanrooms and as part of cross-functional teams in a manufacturing environment.

Qualifications

• Two years of relevant lab experience in a GMP environment.
• Understanding of ISO, USP, GLP, GDP standards.
• Willingness to work in cleanrooms and wear PPE.

Responsibilities

• Maintains the cleanliness and orderliness of laboratory glassware.
• Verifies lab equipment and maintains chemicals and supplies.
• Performs environmental monitoring in ISO classifications.
• Conducts basic microbiological testing on materials and finished products.
• Writes technical reports and updates SOPs and laboratory documents.
• Adheres to GMP, GDP, and safety regulations.

Skills

Metric system

Interpret drawings and specs

Written and verbal communication (EN)

Basic computer skills

Education

BS Degree in Microbiology/related STEM Degree

Tools

Labware

Empower

SAP

Job description

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:

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 cleanrooms, 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 met by an incumbent to successfully perform the essential functions of this job.
2. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions (Per the Americans with Disabilities Act of 1990).
3. The incumbent may be frequently required to stand and/or occasionally sit for extended periods of time. Bending, stooping and reaching are also frequently required. While performing this job, the employee is regularly exposed to episodes of walking, kneeling, balancing, crouching, pushing/pulling, repetitive grasping, hearing, twisting, lifting, frequent use of hand to finger, handle, feel, pick or type which can include repetitive motion of the wrists, hands or fingers.
4. The position will have some exposure to work near moving mechanical equipment, and potential temperature fluctuations.
5. Occasionally the position will have exposure to fumes, airborne particles, hazardous chemicals, cleaning compounds and solvents.
6. The incumbent may be exposed to noise levels in the work environment moderate to loud.
7. The incumbent must be willing and able to wear required PPE such as, safety glasses, face mask and/or shield, hearing protection, safety shoes, hair and beard net and smock.