Carry out cGMP manufacturing operations using Standard Operating Procedures (SOP), Batch Records and Form Preps.
Troubleshoot and resolve basic process related issues including recognizing and escalating deviations
Execution of critical and routine activities to support production.
Perform Batch Record, Logbook and Form Prep requests.
Enter data in the Laboratory Information Management System (LIMS) , or MODA other business systems
Review GMP documentation.
Sample preparation and testing.
Identify changes needed to documentation.
Participate in tiered visual management system and support CI initiatives
Manage equipment and support facility related projects including initiating work orders, assembly and disassembly of process equipment, perform scheduled cleaning and standardization of equipment.
Support change over activities and execution of equipment and process qualifications and validation.
May perform as a subject matter expert for equipment or systems.
Identify process deviations, troubleshoots issues and identifies process improvements.
May require interaction with equipment, technical and supply item vendors.
Qualifications:
Requires a high school diploma and 0-2 years related industry experience or an Associate's Degree in Life Sciences/Engineering field.
Biotech Certificate would be ideal.
Can follow written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
Prior troubleshooting skills and full awareness of current Good Manufacturing Practices.
Proficient computer skills.
May require weekend or holiday off shift support and flexibility to adjust work schedule to meet production demands.
