Title - Scientist II

Duration:

12 Months

Location:

Raritan, NJ

Department:

Manufacturing Quality

Reports To:

Supervisor, Microbiology

Shift:

First Shift

POSITION SUMMARY

Responsible for routine and non-routine microbiological testing according to established procedures and approved protocols. Supports manufacturing quality operations through testing, environmental monitoring, investigations, product release activities, data review, equipment maintenance, and microbiological documentation.

KEY RESPONSIBILITIES

Perform raw material, intermediate, final product, and water testing, including Bioburden and Endotoxin testing.

Perform environmental monitoring (viable and non-viable).

Document results accurately and interpret findings against specifications and requirements.

Investigate and close Microbial Data Excursions (MDEs) using MODA and/or TrackWise.

Perform data reviews and prepare product release documentation to meet production timelines.

Participate in laboratory investigations, technology transfer activities, validations, and R D projects.

Identify microorganisms and enter data into MODA.

Maintain trending spreadsheets and laboratory binders.

Report and trend finished product testing and environmental monitoring results for manufacturing and support areas.

Calibrate and maintain laboratory equipment.

Monitor and maintain laboratory inventory and supplies.

Perform additional work-related duties as assigned.

TIME ALLOCATION

Time

Responsibility

35%

Raw material, intermediate, final product, water testing, Bioburden, Endotoxin testing, and environmental monitoring.

25%

Investigation and closure of Microbial Data Excursions (MDEs) in MODA and/or TrackWise.

10%

Data review and preparation of product release documentation.

10%

Participation in laboratory investigations, technology transfers, validations, and R D projects.

10%

Microorganism identification, MODA data entry, and maintenance of trending records.

5%

Reporting and trending of finished product and environmental monitoring results.

5%

Calibration, maintenance of laboratory equipment, and inventory management.

QUALIFICATIONS

Education

Bachelor's Degree in Biology, Microbiology, Life Sciences, or related scientific discipline.

Experience

3-5 years of laboratory experience in a regulated environment, or an equivalent combination of education and experience.

SKILLS AND KNOWLEDGE

Microbiology testing

Bioburden testing

Endotoxin testing

Environmental monitoring

Product release testing

Laboratory investigations

Microbial identification

MODA

TrackWise

GMP / regulated laboratory environment

Documentation and data review

Laboratory equipment calibration

Trending and reporting

Inventory management

Strong written and verbal communication skills

PHYSICAL REQUIREMENTS

Lift up to 50 pounds.

Manual dexterity for handling laboratory instruments and repetitive tasks.

Ability to stand for extended periods.

Strong written and verbal communication skills.

KEY WORKING RELATIONSHIPS

Internal

Manufacturing/Operations - Product release testing support.

External

Vendors and suppliers - Equipment maintenance and laboratory supplies support.

TRAVEL

No travel required.

Why TalentBurst?

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.