Job Title: Process Operator
We are seeking a Process Operator to join our team at micronizemills. The successful candidate will be responsible for handling client-provided materials, including active pharmaceutical ingredients and excipients, in accordance with company procedures, policies, and cGMP guidelines.
Key Responsibilities:
1. Perform entry-level micronization and milling of hazardous and non-hazardous pharmaceutical actives and excipients.
2. Set up, operate, and monitor production equipment and processes.
3. Document production activities accurately on batch records following good documentation practices (GDPs).
4. Work in a regulated environment, adhering to SOPs and policies, including cGMP standards.
5. Identify, communicate, and document non-routine events, deviations, and GMP deficiencies.
6. Clean processing areas and equipment thoroughly.
7. Maintain clear, consistent, and compliant documentation.
8. Demonstrate adaptability, willingness to learn, and proactive communication for process improvements.
9. Participate in meetings, training, and site projects.
10. Work in a site-based environment, aiming for First Time Right (FTR) performance.
Position Requirements:
* Education: High School Diploma or GED.
* Experience: Dependability, eagerness to learn, prior manufacturing experience preferred, ability to work overtime.
* Skills: Good communication (oral and written), basic math, ability to handle hazardous chemicals with PPE, physical strength and stamina.
Physical and Work Environment:
* Ability to lift up to 44 lbs. individually, with assistance for heavier loads.
* Work safely with high potency APIs and hazardous materials.
* Perform physical tasks such as lifting, climbing, bending, and standing for up to 8 hours.
* Work in loud environments, wear PPE, and pass medical exams as required.
This position is site-based and requires compliance with safety protocols and training.
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