Microbiology & Quality Associates (MQA) provides consulting services to the Pharmaceutical, Biotechnology, Medical Devices and Nutritional product companies. MQA personnel and its associates have many years of experience in quality and microbiology to help resolve any microbiology and quality issues.
- Facility review and validation
- Critical utilities review and validation
- Microbial control program design
- Quality systems review and design
- GMP audits – in-house or external
- Raw material program design
- Quality Control systems review and design
- Validation protocol preparation and executions
- Facility preparation for FDA or EU inspections or PAI
- Microbial, media fill and sterility failure investigations
- Clean room and fill room design and evaluation
- Media fill program design
- Environmental Monitoring
- Clean Rooms
- QC and QA systems
Summary of professional experience:
- 25 years experience in microbiology, quality, compliance and validation.
- Expert knowledge of clean rooms operation and validation.
- Expert knowledge in microbiology procedures (USP, CFR, FDA, EU, AAMI, AOAC and Std. Methods for Water Testing).
- Expert knowledge of environmental monitoring requirements.
- Expert knowledge of QC and QA operations.
- Experience validating QC lab equipment, facilities, critical utilities, QC methods such as TOC, LAL, bioburden and other methods.
- Project management experience.
- Bilingual: English and Spanish