• Under general direction, perform testing and other activities in functions supporting the Quality Control department (Micro/EM, QC Bio-assay and raw materials, as appropriate).

Major Accountabilities:

• Perform Bio-Analytical testing such as qPCR, Flow Cytometry, ELISA, cell count, cell viability.
• Perform micro/EM testing such as environmental monitoring, gram stain, sterility testing, endotoxin, and mycoplasma.
• Maintain controls and reference standards to support testing.
• Follows quality policies.
• Plan and schedule assigned activities.
• Generate trend reports.
• Review/approve data generated by other team members.
• Perform method qualification/optimization of methods as per appropriate protocols.
• Contribute to OOS/OOE investigations and deviation investigations.
• Support 5S and Lean projects.
• Identify potential improvements in project work.
• Interface with regulatory agencies during audits.
• Contribute to assigned projects.
• Knowledge of LabWare LIMS and/or other QC data systems.
• Maintain GMP/GLP quality systems.
• In addition to these primary duties, provide coverage for all appropriate areas and testing.
• Performs other job duties as assigned.

Shift Specifics: Wed-Sat AM shift (rotating 1 week Wed-Sat, 1 week Thu-Sat, 07:30-19:30).

Key Performance Indicators: Deliver quality products and services on time to all customers, internal and external.

Competency Profile:

1. Internal orientation:
   • Thorough understanding of cGMP requirements.
   • Good communication and organizational skills.
   • Ensure customer satisfaction and react to customer requests.
   • Is seen as a competent team player.
2. Others:
   • Strong ability to work independently, compliantly and results driven.
   • Strong analysis and decision-making skills surrounding documentation.
   • Pays attention to detail.
   • Able to proof work and identify non-standard format or wording, and errors within documents.