SENIOR QC CHEMIST

LGM Pharma LLC

Rosenberg, TX

JOB DETAILS
SKILLS
Analysis Skills, Analytical Chemistry, Analytical Method Validation, Biotech and Pharmaceutical, Chemistry, Communication Skills, Corporate Policies, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation, External Audit, FDA (Food and Drug Administration), Fourier-Transform Infrared Spectroscopy (FTIR), GMP (Good Manufacturing Practices), High Performance Liquid Chromatography (HPLC), ICH Regulations, Identify Issues, Industry Standards, Instrumentation, Internal Audit, Laboratory, Laboratory Information Management System (LIMS), Laboratory Systems, Maintain Compliance, Materials Analysis, Mentoring, Multitasking, Presentation/Verbal Skills, Quality Assurance, Quality Assurance Methodology, Quality Control, Regulatory Compliance, Regulatory Requirements, Requirements Management, Research & Development (R&D), Safety Compliance, Safety/Work Safety, Spectroscopy, Standard Operating Procedures (SOP), Time Management, UV/VIS (Ultraviolet-Visible Spectroscopy), Writing Skills
LOCATION
Rosenberg, TX
POSTED
30+ days ago

PRIMARY DUTIES AND RESPONSIBILITIES: Perform routine and non-routine chemical analysis of raw materials, in-process samples, and finished products using validated analytical methods. Operate and maintain laboratory instrumentation such as HPLC, GC, UV-Vis, FTIR, and other analytical equipment. Review and interpret analytical data to ensure compliance with specifications and regulatory requirements. Troubleshoot analytical methods, instrumentation issues, and laboratory processes. Develop, validate, and transfer analytical methods in accordance with industry standards (e.g., USP, ICH, FDA guidelines). Prepare and review laboratory documentation, including test methods, protocols, reports, and SOPs. Ensure all laboratory activities comply with cGMP, safety, and company policies. Train and mentor junior chemists and laboratory technicians. Support internal and external audits and inspections. Maintain accurate and timely documentation in laboratory systems (e.g., LIMS, notebooks). Collaborate with cross-functional teams, including Quality Assurance, Production, and R&D. Assist with investigations related to out-of-specification (OOS) and out-of-trend (OOT) results. QUALIFICATIONS: Bachelor's degree in chemistry or related scientific field required; Master's degree preferred. Minimum of 5+ years of experience in a pharmaceutical or GMP-regulated laboratory. Strong knowledge of analytical techniques such as HPLC, GC, and spectroscopy. Familiarity with cGMP, FDA, USP, and ICH guidelines. Strong analytical, problem-solving, and organizational skills. Ability to work independently and manage multiple priorities. * Excellent written and verbal communication skills. At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.

About the Company

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LGM Pharma LLC