Specialist, Lab Support

About the Role

The Specialist, Lab Support will be responsible for the lifecycle management of chemical reagents, standards, solutions, and laboratory consumables within the QC Chemistry laboratory. This role ensures timely availability, proper qualification, compliant storage, and accurate inventory tracking of all reagents to support analytical testing in accordance with GMP and regulatory requirements.

Key Responsibilities

• Reagent & Standard Management

• Coordinate procurement, receipt, labeling, and distribution of reagents, reference standards, and consumables.

• Prepare, document, and maintain stock solutions, working solutions, and mobile phases as required.

• Ensure reagents and standards meet quality, purity, and certification requirements prior to use.

• Monitor expiration/retest dates and initiate replacement or requalification as needed.

• Inventory Control & Planning

• Maintain real-time inventory of all laboratory reagents and supplies using inventory management systems.

• Forecast reagent demand based on testing schedules and historical usage trends.

• Establish minimum/maximum stock levels to prevent shortages or overstocking.

• Coordinate with procurement and vendors to ensure on-time delivery of materials.

• Compliance & Documentation

• Ensure all reagent-related activities comply with GMP, GLP, and internal SOP requirements.

• Generate and maintain accurate documentation, including:

• Reagent preparation records

• Certificates of Analysis (CoA)

• Lot traceability logs

• Inventory records

• Support internal and external audits by providing reagent traceability and documentation.

• Laboratory Support

• Support QC analysts by ensuring availability of qualified reagents and solutions.

• Troubleshoot reagent-related issues such as variability, contamination, or degradation.

• Coordinate disposal of expired or hazardous materials in accordance with EHS policies.

• Perform daily calibration of pH Meters and Balances.

• Occasionally perform wet chemistry testing in support of Raw Material, Finished Product, and Stability.

• Support chromatographic analysts in preparation of mobile phase, diluent, etc.

• Continuous Improvement

• Identify and implement process improvements in reagent tracking, preparation, and usage efficiency.

• Support digitalization or automation initiatives (e.g., LIMS, inventory systems).

• Standardize reagent preparation and labeling practices across the lab.

Qualifications

• Education

• Bachelor’s degree in chemistry, Biochemistry, or related scientific discipline required.

• Experience

• 0-2 years of experience in a QC laboratory, preferably in a GMP-regulated environment (pharma, biotech, or chemicals).

• Experience with reagent preparation, inventory control, or lab coordination is strongly preferred.

• Technical Skills

• Strong understanding of analytical chemistry techniques (HPLC, GC, UV, wet chemistry).

• Knowledge of reagent stability, storage requirements, and compatibility.

• Experience with LIMS, ERP, or inventory management systems.

• Proficiency in Microsoft Office (Excel for tracking/forecasting is critical).

• Core Competencies

• Detail-oriented with a strong focus on compliance and documentation accuracy.

• Excellent organizational and planning skills.

• Strong communication and cross-functional coordination abilities.

• Ability to manage multiple priorities in a fast-paced lab environment.

• Problem-solving mindset with a proactive approach.