Bulk Lead Technician

The Bulk Lead Technician will assist the Bulk Operations Supervisor with the oversite of production and personnel. The Bulk Lead Technician will work a continuous work week schedule as required by production demands. They will be responsible for ensuring that the process complies with all cGMP and validation requirements, which includes the control of all environmental factors. The Bulk Lead Technician will fill in for the Bulk Operations Supervisor as needed.

Responsibilities:

• Keep track of production numbers in order to complete the daily Line reports as needed
• Manage production data in Epicor
• Identify areas of improvement for Bulk production
• Ensures Bulk areas remain clean and orderly
• Perform silo changes and documents information accordingly
• Issues and returns resin and other materials as needed
• Manage HVAC daily reports
• Perform inspections during batch changeovers
• Sign in and out batch records from QA as needed
• Ensuring the departmental review of Batch Records is performed as required
• Address corrections in batch records and resolves documentation issues with QA as needed
• Assist in training new hire Bulk Associates
• Assist in development/training of new procedures and processes
• Assist with Bulk Associate responsibilities as needed
• Monitor plant utilities equipment to confirm operating as specified
• Communicate openly with all areas of the plant
• Support validation and product development activities as needed

• Prior cGMP experience preferred
• Minimum of 2 years experience in manufacturing preferred
• Proficient in MS Office applications.
• Ability to establish priorities and meet quality expectations with minimal supervision
• Effectively utilize both written and verbal communications skills with internal and external contacts