Cleanroom Production Operator - Sorrento Valley

Immediate Hiring

Cleanroom Production Operator - Sorrento Valley - 2nd shift - $20.35/hr

The Cleanroom Production Operator performs daily production and packaging activities in a controlled cleanroom environment, following Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs). This role focuses on meeting production goals, supporting timely product release, and maintaining high standards of quality and documentation in a regulated manufacturing setting.

Responsibilities

• Perform daily production and packaging tasks in accordance with GMP and all applicable SOPs.
• Work consistently to achieve assigned production goals and support unscheduled peaks in workload to ensure timely release of product and prevent back orders.
• Collaborate with team leadership to understand and follow requirements for critical raw materials, in‑process procedures, and product specifications.
• Participate in identifying and implementing corrective actions for technical issues related to raw materials and finished products.
• Conduct in‑process quality checks on sub‑assemblies and finished products to verify compliance with specifications.
• Recognize and report line issues and other production problems, promptly notifying team leadership so corrective actions can be taken.
• Maintain accurate, complete records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs.
• Use computerized Materials Resource Planning (MRP) and Enterprise Resource Planning (ERP) systems, including lot-controlled ingredient reporting on batch records and closing work orders.
• Perform line clearances and provide clear, accurate examples of how line clearance activities are completed before starting new production runs.
• Operate manufacturing equipment and machinery safely and efficiently in support of production and packaging activities.
• Carry out inspection and quality assurance checks on products and components throughout the production process.
• Use computers and relevant software, including Microsoft Office and ERP systems such as SAP, to support production, documentation, and inventory activities.
• Follow Good Laboratory Practices (GLP), FDA, and ISO-related procedures as applicable to the manufacturing process.
• Participate in qualification and validation trials when needed and support process improvements.
• Adhere strictly to cleanroom protocols, dress code requirements, and safety rules, including use of ear protection and avoidance of personal electronic devices on the manufacturing floor.
• Demonstrate reliability and consistent attendance to avoid bottlenecks in the production process and support overall team performance.
• Remain flexible to work overtime, including occasional Saturdays, as required by production demands.

Essential Skills

• Ability to understand and consistently follow standard operating procedures (SOPs) in a manufacturing environment, including providing detailed examples of how SOPs were applied in previous roles to achieve goals.
• Understanding of Good Documentation Practices (GDP), with the ability to explain what GDP is and how to follow these practices in day‑to‑day work.
• Familiarity with Good Manufacturing Practices (GMP) and their application in production and packaging activities.
• Ability to perform line clearances and clearly describe the steps involved in ensuring lines are properly cleared before new production runs.
• Basic machine operation skills in a manufacturing or production environment.
• Experience or ability to perform quality assurance, packaging, and inspection tasks on sub‑assemblies and finished products.
• Competence in computer operation, including use of Microsoft Office and other basic software tools.
• Previous experience with, or ability to quickly comprehend, coagulation‑based manufacturing processes.
• Familiarity with GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO requirements in a regulated manufacturing environment.
• Ability to maintain accurate records and documentation in line with GDP and SOPs.
• Capacity to work reliably on a set shift and support overtime needs when required.

Additional Skills & Qualifications

• Entry‑level candidates are welcome; no prior…