QC Microbiologist II: Aseptic & EM Specialist (Onsite)

Anika; Bedford (MA); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Discretionary bonus

Comprehensive healthcare benefits

Health Savings Account (HSA)

401(k) with company match

Employee stock purchase plan (ESPP)

Paid time off

Long-term incentives including stock

Job summary

Anika is seeking a QC Microbiologist II to perform routine and complex microbiology testing of materials, in-process samples, and finished products. You will conduct environmental monitoring in ISO 5–8 areas and support aseptic manufacturing operations with strong data integrity.

The role requires independent work under cGMP, adherence to USP/EP/JP pharmacopeia, and collaboration with QA, Manufacturing, and cross-functional teams in a regulated setting.

Qualifications

• Bachelor's degree in Microbiology or related field.
• 2+ years of hands-on experience in a cGMP QC Microbiology lab.
• Experience in classified cleanrooms (ISO 5–8) and EM support.

Responsibilities

• Perform routine and non-routine microbiology testing on materials and products.
• Conduct environmental monitoring in ISO cleanrooms and support media fills.
• Maintain accurate, real-time documentation in LIMS and SOP adherence.
• Support investigations for environmental excursions and deviations.
• Assist with SOPs, test methods, and regulatory readiness.

Skills

Communication skills

Analytical skills

Independent work

Detail-oriented

Education

Bachelor's degree in Microbiology or related field

Tools

LIMS/eQMS systems

BET/LAL software

Bioburden filtration apparatus

Job description

Anika is seeking a QC Microbiologist II to perform routine and complex microbiology testing of materials, in-process samples, and finished products. You will conduct environmental monitoring in ISO 5–8 areas and support aseptic manufacturing operations with strong data integrity.

The role requires independent work under cGMP, adherence to USP/EP/JP pharmacopeia, and collaboration with QA, Manufacturing, and cross-functional teams in a regulated setting.