Laboratory Associate

Quality Santa Cruz, California


Description

As a member of the Quality Laboratory team, the Laboratory Associate reviews all raw data for compliance and accuracy of results, documents any deviation to the current procedures (SOP) or to the analytical methods used for testing, conducts laboratory investigations, prepares certificates of analysis, and drives Corrective and Preventative Actions (CAPAs) and other action items related to laboratory documentation.

 

Duties and Responsibilities

  • Check raw data and ensure all pertinent procedures (SOPs) and analytical methods have been followed when analyzing products and calculating results.
  • Review documentation related to analyses (lab book, UPLC forms, reference standard preparation logbook) in regard to good documentation practices, calculation and reporting of results.
  • Assess the calibration status of instruments and other tools used to perform the testing.
  • Declare and document any deviation using current quality system procedures.
  • Ensure compliance and quality of analysis in respect to analytical methods and current specifications for raw materials and finished products.
  • Document and investigate any out-of-specification (OOS) results according to current procedure.
  • Maintain an up to date OOS list, review any pending items, and close investigations on time.
  • Close laboratory reports and proceed to the release of raw materials.
  • Issue certificates of analysis for finished products in accordance to client specific requirements or market.
  • Work closely with the Laboratory Supervisor to maintain timelines, inform of any deviation or OOS results that may impact delivery deadlines.
  • Participate in archiving the raw data, certificates of analysis and investigation reports.
  • Drive CAPA and other action item follow up.

 

Required Qualifications

  • Bachelor’s degree in Chemistry, Biochemistry or related science.
  • Minimum 5 years of quality control analytical chemistry laboratory experience combined with a minimum of 2 years in a similar role.
  • Strong knowledge and understanding of cGMP and cGLP, data integrity principles, good documentation practices and laboratory investigations.
  • Knowledge of UPLC/HPLC techniques, Empower 3 software audit trail and general chemistry testing for dietary supplements, drug products and/or environmental testing.
  • Ability to remain focused and continuously perform tasks, manage priorities and work under pressure with tight timelines and frequent priority changes.
  • Strong leadership, initiative, autonomy, problem solving, teamwork, organization, results-orientation, communication and interpersonal skills.
  • Courage to inform about any quality event observed or any delay that impacts the established timeline.
  • Proficiency with Microsoft Office including Outlook, Excel and Word.
  • Familiarity with Quality Management Software such as Trackwise, Master Control or SharePoint.

 

Preferred Qualifications

  • Experience in the pharmaceutical industry or any other FDA or Health Canada certified analytical chemistry laboratory.

 

Physical Requirements

The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.