Analyst, QC Analytical

2 weeks ago

San Rafael, United States Compass Consulting Full time
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

Duties:
  • The Quality Control Analyst is responsible for performing microbiological, biochemical and chemical tests of in-process product, equipment, and manufacturing facilities.
  • The incumbent will be responsible for performing microbiological and analytical testing under cGMP guidelines.
  • Functional activities may include: performing a wide variety of tests for microbiological, biochemical, and chemical assays, supporting process validation studies, conducting investigations, analytical method or equipment validation, assay method/procedure development, and reagent preparation.

The position requires knowledge of but is not limited to:
  • HPLC, Enzyme activity, protein by UV spectrophotometry or Bradford/BCA, kinetic chromogenic endotoxin, bio burden determination, Total Organic Carbon, microbial identification, aseptic techniques, microbial challenge studies, microbiological method validation, and other similar analysis methods.
  • Work assignments will encompass activities from routine to complex in nature with the ability to recognize deviations from the accepted or routine practice.
  • The incumbent will be responsible for completing assignments in a timely manner, for assay troubleshooting, data trending, and for follow-up on any testing issues.
  • The incumbent should be able to work independently and prioritize multiple tasks.
  • Good record keeping, organizational, written and verbal communication skills are essential.
  • The incumbent must be willing to work second shift, overtime, weekends and holidays as required.
  • Perform microbiological/ biochemical/ chemical analyses of in-process product, facility and utility testing under cGMP to meet specified timelines.
  • Assist with the preparation of investigations, technical reports and trend reports.
  • Support method validation, transfer, routine, and non-routine study protocols.
  • Control laboratory inventories.
  • Maintain the laboratory in an inspection ready state.
  • Provide backup support of analytical chemistry/biochemistry assays for Analytical and Raw Materials Groups.
  • Provide on call coverage for Action level conditions to support production testing and quality control laboratory equipment.
  • Must have a quality service attitude and be willing to work additional hours to meet production or laboratory requirements when necessary.

Skills:
  • QC cGMP experience beneficial.
  • Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices.
  • Demonstrated working knowledge related to specific functional activities.
  • Ability to perform most tasks with supervision.
  • Computer literacy is required.
  • Experience with Microsoft Word and Excel required; experience with Access and PowerPoint a plus.
  • Must have excellent record keeping, written and verbal skills.
  • Experienced with microbiological methodologies and a variety of analytical instrumentation; capable of troubleshooting assays. Efficient in scheduling and facilitating the execution of routine and non-routine testing.

Education:
  • Bachelor of Science or Bachelor of Arts in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience or Associates of Science with at least 4 years of relevant laboratory experience.

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