Senior Quality Control Analyst

Description

Job Summary: A Physical-Chemical Quality Control professional focused on HPLC, OOS/deviation investigations, and document management within a pharmaceutical environment. Key Highlights: 1. Core expertise in High-Performance Liquid Chromatography (HPLC) 2. Investigation and critical analysis of Out-of-Specification (OOS) results 3. Preparation and review of Quality Control technical documents **Requirements:** Bachelor's degree in Chemistry, Pharmacy, Biology, or related fields; Solid experience in physical-chemical analyses with hands-on HPLC application; Experience in investigating Out-of-Specification (OOS) results, deviations, and defining corrective actions (CAPA); Experience in preparing and reviewing Quality Control technical documents (analytical methods, protocols, reports, specifications, and technology transfer documentation); Familiarity with LIMS systems (preferably Sample Manager), ERP systems (e.g., SAP), and document management systems; Proficiency in Microsoft Office Suite, especially Excel; Basic knowledge of pharmaceutical bioprocesses; Intermediate English proficiency for technical reading; Valid driver's license and personal vehicle; Residence in Valinhos or Campinas, with easy access to the Joapiranga neighborhood (Valinhos). **Responsibilities:** * Perform sample preparation, processing, and reporting of physical-chemical analysis results, with emphasis on **High-Performance Liquid Chromatography (HPLC)**; * Prepare and technically review Physical-Chemical Quality Control documents (protocols, reports, procedures, analytical methods, specifications, user requirements, and technology transfer documents); * Lead the initiation, investigation, and critical analysis of Out-of-Specification (OOS) results and quality deviations; * Support the definition of technical criteria and parameters related to analytical validations and technology transfers; * Participate in Product Development Projects (PDP) and other Quality Control department initiatives; * Configure quality parameters in the ERP system; * Perform and verify analytical records and laboratory technical documentation; * Guide the receipt, storage, and control of laboratory materials, reagents, and consumables; * Develop, monitor, and analyze Quality Key Performance Indicators (KPIs); * Identify Quality Control department needs and track maintenance requests and purchase requisitions; * Ensure compliance with standards and procedures related to the Quality Management System (GMP), environmental, occupational health, and safety requirements; * Maintain laboratory organization, preservation of materials, equipment, and technical documentation. **Salary:** R$6.461,00 + **Night Shift Allowance:** R$369,20 **Benefits:** Transportation Voucher; On-site Meals; Life Insurance. **Working Hours:** Monday to Friday, from 2:30 PM to 11:15 PM. Minimum Education Level: Bachelor's Degree