Scientist II
Raritan, NJ - USA
Job Summary
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
Bachelors Degree in Biology Microbiology Life Sciences or related scientific discipline.
Experience
35 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.
Required Experience:
IC