1St Shift - Technical Operator 1 (Jo-2301-189976)

Technical Operator 1
Location: Mira Mesa, CA 92121
Hours: 1st Shift Monday - Friday 5:30 AM - 2:00 PM
Pay: $18.00/hr
COVID - Vaccinated preferred

An industry leading Medical Device Manufacturer is looking for Technical Operator 1 to join their team.
Job Duties:

• Support daily production and packaging activities in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs). 
• Continually work to achieve assigned production goals; meet unscheduled peaks in workload as necessary to ensure timely release of product and to avoid back orders. 
• Work with Team Leader and Supervisor to detail critical raw materials, in-process procedures, and specifications. 
• Support corrective action for technical problems related to raw materials, finished products; minimize rejects and field complaints. 
• Perform in-process quality checks on sub-assemblies and finish products. 
• Identify line issues and other production problems; promptly notify Team Leader or Supervisor of required corrective action. 
• Support all efforts and procedures to maintain optimal manufacturing conditions. 
• Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs. 
• Maintain safe working conditions at all times; adhere to all safety policies and procedures. 
• Use computerized Materials Resource Planning (MRP) inventory system as required to report lot-controlled ingredients on batch records. 
• As needed, and as directed, support with formulation activities. 
• Operate production equipment as directed and in accordance with all SOPs. 
• Ensure production areas are continually kept clean. 
• Prevent mix-up of products, materials, labels, and other components. 
• As directed, provide support for process and equipment validation. 
• Maintain daily product logbooks as directed. 
• As necessary, and as directed assist with formulation preparations. 
• Ensure and maintain compliance with the Company's quality system requirements through training and adherence to policies, procedures and processes. 

Qualifications:

• High school diploma or equivalent. 
• At least two (2) years previous assembly/packaging experience; previous experience in a regulated medical device manufacturing or pharmaceutical environment strongly preferred. 
• Previous experience with, or ability to, quickly comprehend coagulation-based manufacturing processes. 
• Familiarity with GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO. 
• Knowledge of qualification and validation trials a plus.
• Working knowledge of Microsoft Office and large Enterprise Resources Planning (ERP) system preferred. 
• Good written and verbal communication. 
• Ability to work as part of a team.

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.