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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
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 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.
- 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.