Non-Aseptic Operator I

Role Summary

The Non-Aseptic Production Operator I works in roles including Vial Inspectors, Component Prep, and Compounding/Formulation. Responsible for operating processing and test equipment in environmentally controlled areas per SOPs, including steam sterilizers, formulation tanks and related equipment. Monitors cycles, reviews data to ensure requirements are met, and completes all related documentation.

Responsibilities

• Complies with cGMP through adherence to SOPs, Master Batch Records, and company policies to produce parenteral products with a focus on quality and safety; ensure training is in compliance with job role before performing production activities.
• Ensure equipment is cleaned and maintained; sanitize walls, ceilings, floors, countertops, and tables; prepare and clear production lines before and after operations.
• Review raw process data to verify process standards; apply analytical reasoning and understanding of cGMP production to assess compliance with cycle standards.
• Exercise sound judgment, attention to detail, and the ability to avert situations affecting equipment or product.
• Communicate with Production Management, QA, QC, Maintenance, and Engineering regarding manufacturing operations, equipment reliability, environmental issues, and quality/compliance concerns.
• Monitor manufacturing processes; verify and document production activities manually and on computerized systems (batch records, logbooks) to ensure production requirements are met.
• Maintain a safe work environment and report potentially hazardous conditions to a supervisor.
• Set up and adjust equipment for proper operation; disassemble and install equipment and parts as required; operate various production equipment to support operations.
• Receive, check, store, handle, and deliver bulk and finished drug products; use appropriate material handling equipment per safety policies.

Qualifications

• Required: High School Diploma.
• Required: Minimum one (1) year experience in a regulated environment or a BioWorks Certificate.
• Required: Gowning experience in a classified area.
• Required: Knowledge of cGMPs; basic math and science skills; ability to use a computer; ability to read, understand, interpret, and apply technical writing and instructions; strong verbal and written communication; attention to detail; experience with batch records and pharmaceutical production.
• Preferred: Mechanical aptitude.

Skills

• Strong communication (verbal and written) and documentation skills
• Analytical reasoning and data review capabilities
• Attention to detail and meticulousness
• Ability to follow SOPs and safety protocols precisely
• Mechanical aptitude and aptitude for operating production equipment

Education

• High School Diploma

Additional Requirements

• Physical requirements: continuous standing and walking; frequent bending; lifting and carrying up to 50 lbs; must wear appropriate PPE; health conditions that could affect drug safety must be reported and addressed.