QC Analyst

2 weeks ago


Novato, United States Harvest Technical Services, Inc. Full time
Job DescriptionJob Description

Duties: 

  • The Quality Control Analyst is responsible for performing microbiological, biochemical, and chemical tests of in-process products, 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 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.

The compensation for this position is $28 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.

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