Laboratory Associate II

Responsibilities

Reagent Solution Manufacturing & Preparation

• Prepare GMP compliant solutions following controlled batch records, SOPs, and formulation specifications.
• Perform chemical weighing, solution blending, pH adjustment, filtration, and sterile handling using aseptic technique.
• Ensure material readiness by verifying chemical availability, lot status, expiration, and COA requirements.
• Coordinate preparation of specialized media, including heat labile, light sensitive, or sterile filtered formulations.
• Maintain complete, legible, audit ready documentation in compliance with ISO 9001, and internal quality systems.

Filling Support & Production Operations

• Deliver prepared solutions to filling suites and support filling line operations, including pre use checks, solution transfer, and environmental control.
• Partner with Engineering and Production to troubleshoot fill line issues, material flow, or equipment readiness.
• Ensure product integrity from formulation through final fill.

Laboratory & Equipment Maintenance

• Maintain a clean, organized, and compliant laboratory environment consistent with GMP and clean room expectations.
• Perform equipment pre inspection, verify sterilization cycles, review autoclave printouts, and ensure calibration status.
• Conduct routine cleaning, sanitization, and equipment setup for daily operations.

In Process Testing & Quality Support

• Collect and test in process samples for pH, conductivity, osmolality, appearance, and other QC parameters.
• Document deviations, support root cause investigations, and assist in implementing corrective actions.
• Collaborate with Quality to ensure batch release readiness.

Cross Functional Collaboration & Continuous Improvement

• Participate in process improvement initiatives, reagent reformulation, and workflow optimization.
• Support vendor qualification for new chemical suppliers, including evaluation of material performance.
• Work with R&D to resolve product performance issues and propose alternative solutions.

Training, Leadership & Documentation Ownership

• Provide training, mentorship, and technical guidance to new team members.
• Support cross departmental requests for technical assistance.

Qualifications

• Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemistry or related field, or equivalent education and work experience in a laboratory or manufacturing environment, required.
• Minimum of 1-3 years of experience working in a laboratory or manufacturing environment required that includes the following: knowledge of cGMP; aseptic technique
• Intermediate knowledge of Microsoft Office (Outlook, Word, Excel, Visio, PowerPoint) and Adobe Acrobat required.

Skills/Abilities

• Excellent verbal and written communication.
• Must be able to use discretion and independent judgement.
• Must be able to work in a team environment.
• Must be able to pay close attention to details.
• Must be able to adapt and adjust to a constant changing environment.
• Is required to work from 6:30am – 3:00pm Monday through Friday in the Camarillo, CA office.
• Will occasionally be required to travel.
• May occasionally work evenings and/or weekends as needed.
• Required to wear full six-piece personal protective equipment (PPE) for up to 6–8 hours per day, including eye protection, hair net, lab coat, shoe covers, face mask, and gloves, in accordance with laboratory safety and chemical handling requirements.