QC Microbiologist — GMP Validation & Micro Testing

ANIKA-GCC; Bedford (MA); On-site; USD 66,000 - 82,000; Full time

Benefits offered by this job

Bonus program

Healthcare benefits

Health savings account

401(k) match

Employee stock purchase plan

Paid time off

Stock awards

Job summary

Anika in Bedford, MA is seeking a QC Microbiologist to support GMP manufacturing with microbiological testing, environmental monitoring, and validation activities. You will ensure regulatory compliance, document test results, and collaborate with Engineering and R&D on process validation and new product introductions.

The role requires a Bachelor’s degree in Microbiology or related field, 1 year of pharma testing experience, and strong documentation skills.

Qualifications

• This role requires a Bachelor’s degree in Microbiology or related field or equivalent experience.
• Minimum 1 year of pharmaceutical or regulated industry microbiological testing experience.
• Experience with sterility, bioburden, endotoxin, microbial ID, gram staining, and water testing.
• Knowledge of GMP, GLP, FDA regulations, and ISO requirements.
• Excellent written and verbal communication and documentation skills.

Responsibilities

• Perform microbiological testing for raw materials, in-process samples, and finished products.
• Support environmental monitoring in classified cleanroom environments.
• Review and maintain validation protocols and reports.
• Collaborate with Engineering and R&D on process validation and new product introduction.
• Maintain laboratory records, data integrity, and compliance with SOPs.

Skills

Communication skills

Attention to detail

Documentation and data integrity

Project/time management

GMP/GLP knowledge

Team collaboration

Education

Bachelor's degree in Microbiology

Equivalent experience considered

Tools

Microsoft Office

Job description

Anika in Bedford, MA is seeking a QC Microbiologist to support GMP manufacturing with microbiological testing, environmental monitoring, and validation activities. You will ensure regulatory compliance, document test results, and collaborate with Engineering and R&D on process validation and new product introductions.

The role requires a Bachelor’s degree in Microbiology or related field, 1 year of pharma testing experience, and strong documentation skills.