Specialist Quality Control - 35982

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 is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary

The Specialist Quality Control is responsible for providing scientific and technical expertise to support microbiology laboratory operations, validation activities, and quality systems compliance. This role leads microbiological method validation and technical documentation efforts for new product introductions, investigates quality events, designs specialized studies, and serves as a key technical resource for microbiology-related testing and regulatory compliance activities in a GMP-regulated environment.

Key Responsibilities

• Prepare, review, and approve technical writing reports associated with microbiological method validations and new product introductions.
• Serve as a technical subject matter expert for microbiological testing activities and laboratory investigations.
• Provide scientific and technical support to the Microbiology Laboratory to ensure compliance with GMP requirements.
• Design, execute, and document special studies to support product, process, laboratory, and quality investigations.
• Perform scientific evaluations of microbiological data and trends to support product quality decisions.
• Support deviation owners by evaluating events, performing technical assessments, identifying root causes, and determining appropriate corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams including Quality Assurance, Manufacturing, Validation, Regulatory Affairs, and Technical Services to support operational objectives.
• Review and interpret microbiological testing results to ensure compliance with established specifications and regulatory requirements.

Technical Knowledge & Skills

• Technical writing and report generation for Microbiology Method Validations.
• Knowledge of:
  • Bioburden Testing
  • Bacterial Endotoxin Testing (BET)
  • Low Endotoxin Recovery (LER)
  • Sterility Testing
  • Method Suitability / Method Validation in Microbiology (MMV)
  • Mycoplasma Testing
• Experience with deviation investigations, root cause analysis, and CAPA development.
• Knowledge of GMP, GDP, and microbiological laboratory practices.
• Strong problem-solving, analytical, and technical writing skills.
• Ability to communicate effectively with cross-functional teams and management.
• Experience supporting regulatory inspections and compliance initiatives is highly desirable.

Education

• Doctorate degree in a Scientific discipline; OR
• Master’s degree with 2 years of directly related experience; OR
• Bachelor’s degree with 4 years of directly related experience.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.