Position Description:

The QC Expert Utility Sampling Technician will provide support for Parenteral Operations by performing environmental monitoring of the classified manufacturing areas and by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings. The Technician will assist in providing support in the manufacturing areas during routine environmental monitoring and utility sampling. The Technician will need to understand Aseptic techniques, and will collect samples using appropriate techniques ensuring no contamination.

Key Deliverables:

• Adhere to and promote compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.
• Provide support for Parenteral Operations activities by performing environmental monitoring of classified manufacturing areas.
• Provide support for manufacturing and laboratory activities by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings.
• Participate in department/company continuous improvement projects and initiatives.
• Assist with authoring Standard Operating Procedures and Work Instruction documentation.
• Adhere to and promote compliance of all safety standards.

Requirements:

• Education: High School Diploma or equivalent, Associate Degree is preferred.
• At least one year of experience working within a GMP microbiology laboratory

Nice to Haves:

• Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
• Strong oral and written communication skills for communicating to colleagues, management, and other departments.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
• Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.