QC Specialist/Lead Analyst (Microbiology/Environmental Monitoring)
3-5 years experience
$70K - $90K
Responsibilities include, but are not limited to environmental monitoring, routine testing, method qualification/validations, excursion notifications, and trend reports and other associated activities. A potential candidate will possess an understanding of Environmental Monitoring and Microbiological techniques. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations. The QC Analyst may also support the Manager for activities related to training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. The QC Analyst should be able to work effectively within the group, within Quality, and across site. Responsibilities:
- Perform environmental monitoring for HVAC (viable air, viable surface, total particulates), purified water (conductivity, TOC, bioburden) and compressed gases (hydrocarbon, dew point and bioburden) systems. Serve as subject matter expert in this area.
- Review and trend EM data and publish quarterly and annual trend reports.
- Conduct thorough investigations to determine root cause of environmental excursions and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
- Establish and maintain library of environmental isolates.
- Perform microbiological testing such as bioburden, endotoxin, growth promotion, viability and gram staining, etc.
- Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
- Perform other established analytical methods such as BCA, SDS-PAGE, TOC, conductivity, and pH testing to support QC operations.
- Participate in assay troubleshooting, qualification and validation.
- Manage the use and maintenance of scientific equipment and instrumentation, computer systems;
- Write and revise documents such as SOPs and technical reports.
- Minimum B.A. or B.S. in microbiology or related scientific field
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.