QC Associate II - 3rd Shift

Responsibilities

• Execute critical functions to support the manufacturing of sterile drug products.
• Samples raw materials for chemistry and microbiology testing in clean room classified areas, minimizing contamination using aseptic technique.
• 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.
• Supports the Raw Materials team by aseptically sampling incoming goods for chemical and microbiological testing.
• Learn Chemistry and Microbiology analyses to support timely release of In-Process Control test results and timely completion of batch release.
• 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.

Requirements

• Able to gown aseptically and maintain certification to internal requirements.
• Able to sample aseptically, perform fine measurements using tools and learn new instrumentation.
• Competent 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.

Qualifications

• 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).

Pay

Target Pay Range: $30-32/hour + 15% Shift Differential for working on 3rd Shift (10:00 PM - 6:30 AM Sunday night - Friday morning)

Schedule

QC Associate II, 3rd Shift (10 PM - 6:30 AM Sunday night - Friday morning)