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Analyst, QC Analytical

San Rafael, CA 94901

Posted: 11/30/2023 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 11343 Pay Rate: $26.00 - $28.00

Job Description

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.

Job Requirements

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.

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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