LinkedIn - Jobboard
Microbiologist
LinkedIn - Jobboard, San Diego, California, United States, 92189
Position: Microbiologist
Location: San Diego, CA
Duration: 12+ Months Contract
Total Hours/week: 40.00
Work hours: 9-5pm PSTOnsite3 Must haves on the resume: Clean room validation, bioburden and microbiological testing, and environmental monitoringJob SummaryAs directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting cleanroom validation, environmental monitoring, and product bioburden testing. Successful performance requires close work with quality management, operations, and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.
Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations, ISO 14644 series, and ISO 11737. Preferred core experience in Quality Assurance, Quality Control, Validation (IQ,OQ,PQ). Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)Experience with addressing any internal quality issues and help the team to resolve them in a timely manner with production, quality, and regulatory compliance needs. Part of the MRB team to help create or drive quality notifications to release the material.Experience performing equipment and process validation studies such as writing and/or reviewing protocols, reports, data analysis, and deviations for new, existing, and site relocation activities. Have a working knowledge of medical device or biological equipment maintenance from a Quality standpoint such as Preventive Maintenance, Calibration, and Out Of Tolerance activity support to the site and equipment owners.Experience on CAPA (Corrective Action and Preventive Action) for internal and external complaints or Non-conformance or continuous improvement activities.Experience with CEA validation studies and environmental monitoring and critical systems (i.e., processed water and compressed air) monitoring.Experience with product bioburden monitoring and microbial testing methods.Education And ExperienceBS in Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field. Minimum of 3-5 years of experience in Medical Device, Biotech, or Pharma Industry.
Knowledge And SkillsStrong verbal and written communication skills; ability to write technical documents.Knowledge of quality system methodologies.Basic knowledge of Statistical Analysis (e.g., Minitab or Excel).Strong knowledge of Design Control, Process Validation, and Supplier Management.Strong understanding and knowledge of ISO 9001, ISO 14644, 11737, and/or ISO 13485 (Design Control).SAP knowledge.The ability to work in teams and independently with minimal supervision to obtain results as required.Must be self-motivated/directed, organized, detail-oriented, and have the ability to multi-task projects.Physical Demands: (if applicable)General physical requirements: Sedentary work.Visual acuity requirements: Inspection / Administrative.Motion and sensory requirements: Talking, hearing, and walking.Work Environment: (if applicable)Onsite or hybrid work model is considered.Ability to be present in the manufacturing area as needed to support quality investigation.
#J-18808-Ljbffr
Location: San Diego, CA
Duration: 12+ Months Contract
Total Hours/week: 40.00
Work hours: 9-5pm PSTOnsite3 Must haves on the resume: Clean room validation, bioburden and microbiological testing, and environmental monitoringJob SummaryAs directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting cleanroom validation, environmental monitoring, and product bioburden testing. Successful performance requires close work with quality management, operations, and/or BD associates to assure compliance with all BD quality policies, procedures, and practices.
Must demonstrate a working understanding of the ISO 13485 Quality Systems Regulations, ISO 14644 series, and ISO 11737. Preferred core experience in Quality Assurance, Quality Control, Validation (IQ,OQ,PQ). Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)Experience with addressing any internal quality issues and help the team to resolve them in a timely manner with production, quality, and regulatory compliance needs. Part of the MRB team to help create or drive quality notifications to release the material.Experience performing equipment and process validation studies such as writing and/or reviewing protocols, reports, data analysis, and deviations for new, existing, and site relocation activities. Have a working knowledge of medical device or biological equipment maintenance from a Quality standpoint such as Preventive Maintenance, Calibration, and Out Of Tolerance activity support to the site and equipment owners.Experience on CAPA (Corrective Action and Preventive Action) for internal and external complaints or Non-conformance or continuous improvement activities.Experience with CEA validation studies and environmental monitoring and critical systems (i.e., processed water and compressed air) monitoring.Experience with product bioburden monitoring and microbial testing methods.Education And ExperienceBS in Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field. Minimum of 3-5 years of experience in Medical Device, Biotech, or Pharma Industry.
Knowledge And SkillsStrong verbal and written communication skills; ability to write technical documents.Knowledge of quality system methodologies.Basic knowledge of Statistical Analysis (e.g., Minitab or Excel).Strong knowledge of Design Control, Process Validation, and Supplier Management.Strong understanding and knowledge of ISO 9001, ISO 14644, 11737, and/or ISO 13485 (Design Control).SAP knowledge.The ability to work in teams and independently with minimal supervision to obtain results as required.Must be self-motivated/directed, organized, detail-oriented, and have the ability to multi-task projects.Physical Demands: (if applicable)General physical requirements: Sedentary work.Visual acuity requirements: Inspection / Administrative.Motion and sensory requirements: Talking, hearing, and walking.Work Environment: (if applicable)Onsite or hybrid work model is considered.Ability to be present in the manufacturing area as needed to support quality investigation.
#J-18808-Ljbffr