Quality Assurance Analyst
hace 20 horas
Job DescriptionThe Quality Assurance (QA) Analyst is responsible for ensuring that health and wellness products are manufactured, tested, released, and distributed in compliance with applicable regulatory requirements, quality standards, and company policies. The role supports Good Manufacturing Practices (GMP), quality system implementation, and continuous improvement initiatives to ensure product safety, efficacy, and consistency.Quality Systems & ComplianceEnsure compliance with GMP, GDP, and relevant quality standards (e.g., FDA, DOH, ISO 9001/22000, HACCP, as applicable).Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).Participate in internal audits, regulatory inspections, and third-party audits; assist in audit preparation and follow-through on corrective actions.Documentation & Records ManagementReview, control, and maintain quality documentation including SOPs, batch manufacturing records, specifications, protocols, and reports.Ensure proper documentation practices (GDP) are consistently followed across manufacturing and quality operations.Assist in document change control, deviation reports, and CAPA documentation.Product Quality & ReleaseReview batch records and test results to support product disposition and release decisions.Monitor in-process controls and finished product specifications to ensure compliance with approved standards.Coordinate with Production, QC, and Warehouse teams to resolve quality-related issues.Investigate deviations, non-conformances, and customer complaints related to product quality.Support root cause analysis and development of corrective and preventive actions (CAPA).Track CAPA effectiveness and ensure timely closure.Assist in supplier qualification, evaluation, and monitoring activities.Review Certificates of Analysis (COA) and ensure raw materials and packaging materials meet quality requirements.Support incoming material inspection and vendor-related quality concerns.Support GMP and quality-related training programs for employees.Promote quality awareness and a culture of compliance within the organization.Participate in continuous improvement projects to enhance process efficiency and product quality.QualificationBachelor’s degree in Pharmacy, Chemistry, Biology, Food Technology, Chemical Engineering, or a related science discipline.Must be willing to work in Alaminos, Laguna.ExperienceAt least 1-2 years of quality assurance experience in pharmaceutical, nutraceutical, food supplement, cosmetic, or health and wellness manufacturing.Experience working in a GMP-regulated environment is required.Strong knowledge of GMP, quality systems, and regulatory requirements.Proficient in documentation review, deviation investigation, and CAPA management.Detail-oriented with strong analytical and problem-solving skills.Effective communication and cross-functional collaboration skills.Ability to manage multiple priorities in a fast-paced manufacturing environment. #J-18808-Ljbffr
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Quality Assurance Analyst: GMP, CAPA
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veracruz, México Artico Cold Chain A tiempo completoA cold storage company is looking for a Quality Assurance Specialist to ensure compliance with health and safety standards. Responsibilities include monitoring storage temperatures, inspecting product quality during receiving and dispatch, and conducting internal facility audits. Candidates should have a degree in Food Technology or a related field and...
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