Microbiology QC Specialist – GMP Validation Expert

Mirus Consulting Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Specialist Quality Control to provide scientific and technical expertise for microbiology operations, validation activities, and quality systems in a GMP environment.

The role leads microbiological method validation, investigates quality events, designs studies, and acts as a technical resource for testing and regulatory compliance. Doctorate or relevant Master/Bachelor with experience required.

Qualifications

• Doctorate or Master’s with relevant experience in GMP-regulated microbiology.
• Bachelor’s with 4+ years related experience accepted as alternative.
• Strong technical writing and scientific communication required.

Responsibilities

• Prepare, review, and approve technical reports for microbiological method validations and new product introductions.
• Serve as SME for microbiological testing activities and investigations.
• Provide scientific support to the Microbiology Laboratory to ensure GMP compliance.
• Design and document special studies supporting investigations and product/process quality.
• Evaluate microbiological data and trends to support product quality decisions.
• Assist deviation owners with investigations, root cause analysis, and CAPA development.
• Collaborate with QA, Manufacturing, Regulatory Affairs, and Technical Services to support objectives.
• Review and interpret microbiological results for regulatory compliance.

Skills

Technical writing

Bioburden testing

Endotoxin testing

Sterility testing

MMV

Mycoplasma testing

CAPA investigations

GMP/GDP knowledge

Regulatory inspections support

Cross-functional collaboration

Education

Doctorate in a scientific discipline

Master’s with 2+ years related experience

Bachelor’s with 4+ years related experience

Job description

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Specialist Quality Control to provide scientific and technical expertise for microbiology operations, validation activities, and quality systems in a GMP environment.

The role leads microbiological method validation, investigates quality events, designs studies, and acts as a technical resource for testing and regulatory compliance. Doctorate or relevant Master/Bachelor with experience required.