Production Specialist

Production Specialist / Senior Manufacturing Consultant (Contract-to-Hire)

Location: Rancho Bernardo, San Diego, CA

Schedule: 5 days onsite | 40-hour work week

Employment Type: 6-month contract-to-hire

Experience Level: Open to candidates ranging from Production Specialist level through Senior Manufacturing Consultant based on experience and qualifications

Position Overview

We are seeking laboratory and manufacturing professionals at varying experience levels — from Production Specialists to Senior Manufacturing Consultants — to support product validation, manufacturing operations, and quality-driven production activities in our Rancho Bernardo, San Diego facility.

This is a hands-on, onsite role responsible for supporting routine manufacturing execution, product validation prior to regulatory approval, quality control testing, and process improvement initiatives. Depending on experience level, candidates may contribute as individual contributors in production operations or take on broader responsibilities related to process optimization, technical oversight, and manufacturing leadership.

This opportunity is ideal for candidates with experience in laboratory manufacturing, quality systems, regulated environments, and diagnostic or life sciences production.

Key Responsibilities

• Execute Manufacturing Batch Records (MBRs) for pilot lots and commercial production orders
• Perform Test Records for in-process quality control (QC) testing and receiving inspections
• Maintain raw materials inventory and stock to support manufacturing schedules
• Prepare laboratory reagents, buffers, aliquots, and support routine lab operations
• Operate and maintain laboratory equipment, including:
• pH meters
• Spectrophotometers
• Centrifuges
• Strip readers
• Ensure compliance with the Quality Management System (QMS) and Good Documentation Practices (GDP)
• Maintain accurate production, QC, and inventory documentation
• Communicate proactively with supervisors, managers, and cross-functional teams to ensure timely task execution
• Work safely with human blood products and common laboratory chemicals in accordance with safety procedures
• Support the R&D team as needed on validation or development-related activities

Additional Responsibilities (Senior-Level / Consultant Candidates)

• Provide technical leadership and oversight for manufacturing operations and production workflows
• Identify and implement process improvements to increase efficiency, quality, and scalability
• Support troubleshooting of manufacturing deviations and quality-related issues
• Assist with manufacturing readiness for product validation and regulatory support activities
• Mentor junior production staff and provide training on SOPs, batch records, and quality processes
• Partner with leadership on production planning, operational improvements, and process optimization initiatives

Qualifications

Production Specialist Level

• Associate’s (A.S.) or Bachelor’s (B.S.) degree in Biology, Chemistry, or related scientific field preferred
• Minimum 1+ year of laboratory, manufacturing, or production experience
• Experience following SOPs, batch records, or laboratory documentation processes preferred
• Strong attention to detail and organizational skills
• Ability to work effectively in a team-oriented environment

Mid-Level Manufacturing / Production Professionals

• 3+ years of experience in laboratory manufacturing, QC, production, or regulated environments
• Experience with QMS, GDP, and manufacturing documentation
• Ability to troubleshoot routine production issues and support process improvements
• Strong communication, organization, and time management skills

Senior Manufacturing Consultant Level

• 5+ years of experience in manufacturing, production operations, diagnostics, life sciences, or regulated laboratory environments
• Demonstrated experience leading process improvements, technical operations, or manufacturing initiatives
• Strong knowledge of quality systems, batch records, QC processes, and regulated production workflows
• Experience mentoring teams, supporting cross-functional operations, and driving manufacturing efficiency preferred

Preferred Skills

• Experience in regulated manufacturing or diagnostic production environments
• Familiarity with ISO quality systems or similar regulated frameworks
• Knowledge of QC testing, production workflows, and laboratory safety procedures
• Process improvement or continuous improvement experience is a plus