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Job Summary:

The Lab Assistant supports laboratory operations in a cGMP-regulated environment by performing routine laboratory tasks, maintaining accurate documentation, and ensuring compliance with established procedures and quality standards. This role assists laboratory personnel with sample handling, equipment preparation, inventory management, and housekeeping activities while adhering to all safety, data integrity, and regulatory requirements. The Lab Assistant plays a key role in maintaining an organized, compliant, and efficient laboratory to support testing, analysis, and quality objectives.

Hours: Monday-Friday, 10am-6:30pm

Responsibilities:

• Prepare media, reagents, dilutions, and controls as needed for routine testing.
• Conducts routine maintenance and safety checks on lab equipment to ensure working order.
• Assists with receipt and inspection of raw materials and the ordering and stocking of materials and equipment.
• Responsible for cleaning, disinfecting, and maintaining cleanrooms and equipment.
• Record all testing activities in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).
• Follow all SOPs, test methods, and work instructions without deviation unless approved through the change control process.
• Maintain accurate instrument logs, calibration records, and laboratory notebooks.
• Support quality audits and regulatory inspections as needed.
• Operate laboratory instruments such as micro-osmometers (e.g., OsmoTECH Pro), pH meters, microscopes, particle counters, TOC meters (if applicable), and microbiology identification systems.
• Perform routine instrument calibrations, verifications, and daily system suitability checks.
• Document equipment usage and maintenance activities.
• Troubleshoot basic issues and escalate instrumentation problems to supervisors, quality, or engineering.
• Maintain a clean, organized, and compliant laboratory workspace, including adherence to aseptic techniques and contamination control practices.
• Comply with all laboratory safety policies, including proper PPE use and handling of hazardous materials.
• Other duties as assigned.

Required Skills/Abilities:

• Excellent verbal and written communication skills.
• Attention to Detail: Ensures accuracy in testing, data entry, and documentation.
• Technical Proficiency: Able to execute complex laboratory methods with minimal supervision.
• Problem Solving: Identifies issues promptly and contributes to laboratory investigations.
• Communication: Clearly documents findings and communicates issues to management.
• Teamwork: Collaborates effectively in a cross-functional environment.
• Compliance Mindset: Demonstrates strong cGMP ethics and commitment to data integrity and impartiality.

Education and Experience:

• Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
• 0-3 years of laboratory experience in a regulated environment (503B, 503A, CGMP, Pharmaceutical QC, GLP, or similar).
• Proficiency in Microsoft Office, LIMS/ELN platforms, and data entry.

Physical Requirements:

• Ability to stand for extended periods while performing laboratory procedures.
• Ability to lift up to 25 lbs. (media, solvent containers, equipment parts).
• Work performed in controlled cleanroom and laboratory environments.
• Position may require occasional weekend, holiday, or off-shift work depending on production needs.