BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a QC Microbiology Analyst to work for a leading San Diego biotechnology company.
QC Microbiology Analyst
Performs quality control activities in order to determine acceptability to appropriate standards, guidelines and conformance criteria specified in procedures, work instructions, drawings and product (parts, sub-assemblies and finished) specifications.
Responsible for providing high level microbiological support for raw materials, in-process, and finished product testing, and for basic method development/validation.
Prepares cultures, maintains product quality, confirms product specifications, and maintains a clean and safe work environment.
Documents, reviews and reports quality results.
Provides support for ongoing microbial testing of USP Purified Water system, Pure Steam and WFI system, Clean Compressed Air system, and environmental monitoring of ISO 5, 6, 7 and 8 cleanrooms.
Provides in-process and finished product inspections to ensure product conformance to specifications and end product requirements.
Conducts trending and reports on investigations to support corrective/preventive action and non-conformance resolutions for microbiological results of environmental monitoring, raw materials, in-process, and finished product testing.
Supports test method, process, and software validations activities as well as supports document control and internal quality auditing requirements.
Supports Product Complaint Investigations.
BA/BS degree in Microbiology or related field
5-8 years experience in Medical Device or Pharmaceutical industry, or equivalent combination of education and experience.
Possess a good understanding of QC Microbiology procedures.
Excellent oral and written communication skills.
Ability to work independently with minimum supervision.
Experience with aseptic techniques, staining and streak plating.
Must have a good knowledge of GMP and FDA regulations.