Microbiology Scientist - QC & Projects (Hybrid)

Celltrion Branchburg; Branchburg Township (NJ); Hybrid; USD 71,000 - 116,000; Full time

Benefits offered by this job

PTO

Holidays

Medical insurance

Dental insurance

Vision insurance

Life insurance

Retirement plan

Wellness programs

Disability benefits

Job summary

Celltrion Branchburg, LLC seeks a QC Microbiology professional to perform routine testing and support investigations in a regulated environment. You will generate and revise technical documents, train staff, and assist in special microbiological projects while applying cGMP and ALCOA principles.

You will conduct testing on water, in-process materials, final products, and environmental samples; identify organisms; and ensure equipment calibration, document control, and trend reporting.

Qualifications

• Experience in routine QC microbiology testing in regulated environments.
• Ability to prepare and revise SOPs, protocols and trend reports.
• Capable of training new or existing staff on procedures.
• Strong technical writing and problem-solving skills.
• Familiarity with cGMP and ALCOA principles.

Responsibilities

• Perform routine QC microbiology testing on water, in-process materials, and products.
• Identify organisms and conduct Bioburden, Endotoxin, Sterility, and related tests.
• Maintain microbial stock culture and assist in special projects/ validations.
• Create, revise, or review documents such as SOPs and deviation investigations.
• Train analysts and ensure calibration/maintenance of lab equipment.

Skills

Teamwork / communication

Attention to detail

Independent work

MS Office proficiency

Flexibility for weekends/overtime/hols

MODA / LIMS / SmartLab / TrackWise

cGMP knowledge

Education

AS degree with 2+ years experience

BS/MS with 0+ years experience

Tools

MODA

LIMS

SmartLab

TrackWise

Job description

Celltrion Branchburg, LLC seeks a QC Microbiology professional to perform routine testing and support investigations in a regulated environment. You will generate and revise technical documents, train staff, and assist in special microbiological projects while applying cGMP and ALCOA principles.

You will conduct testing on water, in-process materials, final products, and environmental samples; identify organisms; and ensure equipment calibration, document control, and trend reporting.