Jobs · Quality Assurance · California

Head of Quality & Compliance

Planet Pharma · Irvine, CA · 1 wk ago
Quality AssuranceContract

Technical Transfer Specialist – Manufacturing Operations

About the role

Supports the implementation of new technologies and processes in manufacturing operations.

Responsibilities

  • Develop and execute technical transfer plans
  • Collaborate with cross-functional teams to ensure successful technology transfer
  • Provide technical guidance and training to manufacturing staff
  • Document and maintain technical transfer records

Requirements

  • Bachelor's degree in Engineering, Science, or related field
  • Minimum 3 years of experience in technical transfer or related field
  • Strong knowledge of manufacturing processes and quality systems
  • Excellent communication and problem-solving skills

Qualifications

  • Experience with regulatory requirements and documentation
  • Ability to work independently and as part of a team
  • Proficiency in Microsoft Office Suite

Skills

  • Technical writing and documentation
  • Project management
  • Quality assurance

Benefits

  • Flexible schedule
  • Professional development opportunities
  • Competitive compensation package

Pay

  • $50 - $60 per hour

Schedule

  • Variable hours based on project needs

QA GCP, Inspection Readiness Contractor

Supports the preparation and execution of Quality Assurance Good Clinical Practice (GCP) and inspection readiness activities.

Responsibilities

  • Prepare and review clinical trial protocols and study reports
  • Coordinate with regulatory agencies and sponsors to ensure compliance
  • Oversee the implementation of GCP guidelines
  • Assist in the preparation of inspection reports and presentations

Requirements

  • Bachelor's degree in a relevant field
  • Minimum 5 years of experience in clinical research or related field
  • Knowledge of GCP standards and regulatory requirements
  • Strong organizational and communication skills

Qualifications

  • Experience with electronic data capture systems
  • Ability to manage multiple projects simultaneously
  • Proficiency in statistical analysis software

Skills

  • Regulatory affairs
  • Data management
  • Statistical analysis

Benefits

  • Health insurance
  • Employee assistance program
  • Flexible work schedule

Pay

  • $70 - $80 per hour

Schedule

  • Variable hours based on project needs

Contract Manager, Clinical Supply Chain

Manages the supply chain for clinical trials, ensuring timely and cost-effective delivery of materials.

Responsibilities

  • Plan and coordinate clinical supply chain activities
  • Manage vendor relationships and negotiate contracts
  • Ensure compliance with regulatory requirements and sponsor guidelines
  • Monitor inventory levels and forecast demand

Requirements

  • Bachelor's degree in Supply Chain Management, Business Administration, or related field
  • Minimum 5 years of experience in clinical supply chain management
  • Strong understanding of regulatory requirements and industry best practices
  • Excellent negotiation and relationship-building skills

Qualifications

  • Experience with clinical trial supply chain systems
  • Knowledge of GCP and ICH guidelines
  • Proficiency in project management tools

Skills

  • Supply chain management
  • Regulatory affairs
  • Vendor management

Benefits

  • Health insurance
  • Employee assistance program
  • Professional development opportunities

Pay

  • $45 - $55 per hour

Schedule

  • Variable hours based on project needs

Production Technician – 1st shift

Operates production equipment and performs quality control checks to ensure product quality.

Responsibilities

  • Operate production machinery and perform routine maintenance
  • Perform quality control inspections and document findings
  • Follow safety procedures and report incidents
  • Participate in continuous improvement initiatives

Requirements

  • High school diploma or equivalent
  • Minimum 2 years of experience in manufacturing or related field
  • Basic knowledge of safety protocols and quality systems
  • Attention to detail and strong problem-solving skills

Qualifications

  • Experience with specific production equipment
  • Ability to work independently and follow instructions
  • Proficiency in basic math and reading comprehension

Skills

  • Maintenance and troubleshooting
  • Quality control
  • Mathematics

Benefits

  • Health insurance
  • Employee assistance program
  • On-site training opportunities

Pay

  • $15 - $20 per hour

Schedule

  • First shift: 06:00 AM - 04:00 PM

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