QC Microbiologist II - Aseptic & EM Specialist

Anika Therapeutics; Bedford (MA); On-site; USD 66,000 - 82,000; Full time

Benefits offered by this job

Discretionary bonus

Comprehensive healthcare

401(k) with company match

Employee stock purchase plan

Job summary

Anika Therapeutics is seeking a Quality Control Microbiologist II to join our Bedford, MA team. The role focuses on routine and complex microbiological testing of materials, in-process samples, and finished products in a highly regulated environment.

The position requires experience in cleanrooms and environmental monitoring, with strong knowledge of USP pharmacopeia and data integrity. The company offers a comprehensive benefits package and competitive compensation.

Qualifications

• Bachelor’s degree in Microbiology or closely related field.
• 2+ years in a cGMP QC Microbiology lab in pharma/biopharma/medical device.
• Experience in cleanrooms ISO 5–8 and EM support for aseptic manufacturing.
• Proficiency with USP pharmacopeia and cGMP/FDA/EMA guidelines.
• Experience with BET/LAL software, particle counters, and LIMS/eQMS systems.

Responsibilities

• Performs routine and complex microbiological testing on raw materials, in-process samples, finished products, and utilities.
• Maintains accurate documentation in notebooks, logbooks, and LIMS following ALCOA+ principles.
• Conducts environmental monitoring in ISO 5–8 areas, including air, surfaces, and personnel monitoring.
• Supports aseptic process simulations and commercial fill-finish operations.
• Authors and revises SOPs, test methods, and validation protocols.
• Supports audits and inspection readiness activities.

Skills

Microbiology testing

Environmental monitoring

cGMP compliance

Documentation

Aseptic processing

Regulatory knowledge

Problem solving

Communication

Education

B.S. in Microbiology

Tools

LIMS

eQMS

BET/LAL

Bioburden filtration

Microbial ID systems

Pipetting

Job description

Anika Therapeutics is seeking a Quality Control Microbiologist II to join our Bedford, MA team. The role focuses on routine and complex microbiological testing of materials, in-process samples, and finished products in a highly regulated environment.

The position requires experience in cleanrooms and environmental monitoring, with strong knowledge of USP pharmacopeia and data integrity. The company offers a comprehensive benefits package and competitive compensation.