Senior QC Microbiology Associate I - Lead Testing & EM/UM

Biogen, Inc.; North Carolina; On-site; USD 81,000 - 105,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Paid vacation & holidays

401(k) matching

Tuition reimbursement

Job summary

Biogen, Inc. in Research Triangle Park, NC is seeking a Sr Associate I in Quality Control Microbiology to support in-process and raw material testing, environmental monitoring, and method qualification.

The role leads lab operations, assists with investigations, and ensures data integrity in a GMP environment. The successful candidate will perform microbiology testing (bioburden, endotoxin), environmental monitoring, and LIMS data review, while training others and maintaining SOPs.

Qualifications

• Bachelor’s degree in Microbiology or related field; minimum 4 years of pharmaceutical microbiology experience
• GMP-regulated manufacturing experience required; rigorous data integrity and documentation discipline
• Experience with environmental monitoring, bioburden, endotoxin, plate reading, and microbial IDs
• Familiarity with LIMS and electronic notebooks; good statistical data analysis skills
• Ability to follow procedures, perform investigations, and work in a cleanroom environment

Responsibilities

• Review test data in LIMS and electronic notebooks
• Prepare quarterly EM/UM reports and support testing for qualification studies
• Perform microbiology testing (bioburden, endotoxin, aseptic techniques)
• Conduct environmental monitoring in controlled manufacturing areas
• Maintain lab cleanliness, equipment, and inventory; assist investigations
• Follow SOPs and controlled documents; ensure safety compliance

Skills

LIMS experience

Microbiological assays

Aseptic techniques

Data analysis

Documentation control

MS Word / Excel

Education

Bachelor’s in Microbiology

B.S. in Biology

Tools

LIMS systems

Veeva

Kneat

MALDI

MicroSeq

Job description

Biogen, Inc. in Research Triangle Park, NC is seeking a Sr Associate I in Quality Control Microbiology to support in-process and raw material testing, environmental monitoring, and method qualification.

The role leads lab operations, assists with investigations, and ensures data integrity in a GMP environment. The successful candidate will perform microbiology testing (bioburden, endotoxin), environmental monitoring, and LIMS data review, while training others and maintaining SOPs.