Laboratory Analyst

Department: Quality Control (QC) Laboratory Reports To: Director of Quality Position Summary The Laboratory Analyst is responsible for performing chemical and/or microbiological testing of raw materials, in-process materials, finished products, environmental samples, and stability samples to ensure compliance with FDA regulations, current Good Manufacturing Practices (cGMP), company specifications, and applicable pharmacopeial standards. The Laboratory Analyst supports product quality by generating accurate analytical data, maintaining laboratory equipment, and documenting all activities in accordance with regulatory requirements. Essential Duties and Responsibilities Perform routine and non-routine laboratory testing of raw materials, finished products, stability samples, and in-process materials. Conduct analytical testing using laboratory instrumentation including: HPLC UPLC GC UV/Vis Spectrophotometer FTIR Dissolution Apparatus pH Meters Analytical Balances Prepare standards, reagents, solutions, and mobile phases according to approved procedures. Review and interpret analytical data for accuracy and compliance with specifications. Perform laboratory investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), and laboratory deviations. Execute testing according to USP, EP, FDA, ICH, and internal methods. Document all laboratory activities in accordance with Good Documentation Practices (GDP). Maintain laboratory notebooks, electronic laboratory systems, and testing records. Assist in method validation, method verification, and method transfer activities. Calibrate and maintain laboratory instruments and equipment. Participate in stability testing programs. Support environmental monitoring and water testing programs as required. Assist during internal, customer, and regulatory audits. Follow all safety, environmental, and cGMP procedures. Maintain a clean, organized, and inspection-ready laboratory. Participate in continuous improvement initiatives. Perform other duties as assigned. Qualifications Education Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related scientific discipline required. Experience 2–5 years of laboratory experience in a pharmaceutical, biotechnology, or regulated manufacturing environment preferred. Experience working under FDA cGMP regulations required.Experience with analytical instrumentation preferred. Required Knowledge, Skills & Abilities Strong understanding of FDA cGMP regulations Knowledge of USP, EP, and ICH guidelines Familiarity with laboratory investigations (OOS/OOT) Excellent analytical and problem-solving skills Strong attention to detail Ability to interpret analytical data Strong organizational and time management skills Ability to prioritize multiple assignments Strong written and verbal communication skills Ability to work independently and collaboratively Proficiency in Microsoft Office Suite Experience with LIMS, Empower, LabWare, or similar laboratory software is preferred Preferred Technical Skills Experience with one or more of the following: HPLC UPLC Gas Chromatography (GC) FTIR Dissolution Testing pH Analysis Stability Studies Method Validation Method Transfer Data Integrity (ALCOA+) Physical Requirements Ability to stand for extended periods. Ability to lift up to 25 pounds. Manual dexterity to operate laboratory equipment. Ability to wear appropriate Personal Protective Equipment (PPE). Visual acuity required for data review and instrument operation. Pharmaceutical manufacturing facility Quality Control laboratory environment Exposure to laboratory chemicals and solvents Must comply with all safety, environmental, and cGMP requirements Key Performance Indicators (KPIs) On-time completion of laboratory testing Right-first-time analytical results Data integrity compliance Laboratory documentation accuracy Instrument uptime and calibration compliance Audit readiness Regulatory compliance Core Competencies Attention to Detail Analytical Thinking Integrity and Ethics Teamwork Communication Accountability Time Management Regulatory Compliance Problem Solving Equal Opportunity Employer We are an Equal Opportunity Employer and are committed to creating an inclusive workplace for all employees. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under applicable law. #J-18808-Ljbffr Belleview Bioscience LLC