QC Support Analyst 4 in San Diego, CA at Apex Life Sciences

Date Posted: 5/10/2018

Job Snapshot

Job Description


Duties:

  • We are seeking a QC Support Analyst responsible for generating accurate and reliable data for biologic products or medical devices on stability.
  • Performs routine testing including release testing, performance testing, analytical testing, bioburden testing, environmental monitoring using GMP/GLP practices.
  • Performs data analysis and results interpretations comparing to specifications, validity criteria, alert limits.
  • Responsible for maintaining product and QC material inventories.
  • Responsible for the maintenance and cleanliness of the laboratory, stocking shelves/drawers with testing materials.
  • Responsible for the maintenance and cleanliness of equipment, calibrating or submitting items for calibration as needed.
  • Responsible for completing training in a timely manner and maintaining the records.
  • Responsible for revising QC documents (SOPs, QSs) Participates in Lab Investigations and Out of Specification investigations.
  • Responsible for training QC analysts on test methods.
  • Participates or leads a QC department team. 

Skills:

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  •  Working knowledge of GMP/GLP.
  • Intermediate computer skills.
  • Attention to detail. 3-5 years of relevant experience.
  • QC experience in an FDA regulated environment is highly desirable.
  • LIMS experience helpful.

Education:

  • Bachelors degree



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