Quality Control Support Analyst
San Diego Metro Area, CA
The primary job function of the QC Support analyst 4 is to perform environmental monitoring, sample and test purified water, microbial identification, media growth promotion bioburden testing to release raw materials and sub-assemblies or finished goods.
Execute routine environmental monitoring of controlled rooms, manufacturing bulk and fill processes per applicable SOP.
Collect purified water samples and perform microbial enumeration and other microbiological test of samples such as raw materials and finished good following GMP/GLP practices.
Performs data analysis and results interpretations comparing to specifications, validity criteria, alert limits.
Participate in QC Method Qualifications
o Responsible for revising QC documents (SOPs, QSs)
o Participates in Lab Investigations and Out of Specification investigations.
May act as the primary QC trainer in specific test methods
May be responsible for writing non-conformance investigations with the assistance of a QC Specialist or Supervisor
May lead a small team for continuous improvement projects
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.
Extremely important that candidates MUST have Environmental Monitoring experience.
Working knowledge of GMP/GLP.
Intermediate computer skills.
Some technical writing skills.
Attention to detail.
Ability to lift up to 25 lbs.
Hep B Vaccine notification required for this position.
BA or BS in a biological science or chemistry
2-4 years experience