QC Associate II - 3rd Shift

Siegfried•Irvine, CA

5d•Onsite

About The Position

The Quality Control Associate II will execute critical functions to support the manufacturing of sterile drug products. Supports the Raw Materials team by aseptically sampling incoming goods for chemical and microbiological testing. Performs environmental monitoring and evaluates results in an aseptic manufacturing facility to support the production of sterile drug products. Performs physical testing using instrumentation and dimensional analysis of components used in the manufacture of sterile drug products. The QC Associate will also learn Chemistry and Microbiology analyses to support timely release of In-Process Control test results and timely completion of batch release.

Requirements

Able to gown aseptically and maintain certification to internal requirements.
Ability to sample aseptically, perform fine measurements using tools and learn new instrumentation.
Competency with routine software programs (i.e. MS Word, MS Excel).
Aptitude for learning new programs (i.e. Labware LIMS, SAP).
Capable of using good reason and judgment to make and defend recommendations.
Positive team player in a fast-paced environment.
B.A or B.S. in Microbiology (preferred), Chemistry or other Pharmaceutical-relevant degree will be considered
3+ years of Experience in QC or QA (preferred)
3+ years of Experience in FDA Regulated industry (preferred)

Responsibilities

Perform sampling of raw materials for chemistry and microbiology testing in clean room classified areas, minimizing contamination using aseptic technique.
Execute Environmental Monitoring program, including viable and nonviable sampling and data analysis.
Perform sampling and inspection in compliance with cGMP.
All activities performed in GMP/GDP environment.
Support media fills through personnel monitoring, scribing aseptic behavior and reading cultures after incubation.
Document raw data contemporaneously and report results promptly.
Utilize assigned NB's and LIMS system.
Execute support functions (i.e. washing glassware, preparing media, running autoclave, changing charts).
Maintain the working areas in a clean and organized state.
Assist in Quality oversight of warehouse operations.