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