Quality Assurance Specialist

WaveCrest Staffing Group is seeking an experienced Quality Assurance Specialist to support a leading pharmaceutical manufacturing organization in Vista, CA. This role will support day-to-day quality operations, lead complex quality investigations, and ensure compliance with FDA and international regulatory requirements in a GMP manufacturing environment.Location: Vista, CAPay: $40–$45/hour, depending on experienceSchedule: Monday–Friday, 8:00 AM–5:00 PMDuration: Contract through June 2027Key ResponsibilitiesServe as the designated QA reviewer and approver for critical site quality events, including deviations, CAPAs, and OOS investigations.Lead complex, cross-functional investigations involving critical deviations, OOS results, and non-conforming materials.Conduct root cause analysis (RCA) to identify underlying issues, assess risks, and determine appropriate corrective actions.Facilitate cross-functional investigation teams to resolve quality issues and implement effective solutions.Author and technically review thorough, audit-ready investigation reports.Develop, track, and implement CAPA plans to address systemic quality risks and prevent recurrence.Evaluate CAPA effectiveness to ensure corrective actions are successful and reduce recurring quality events.Generate and analyze quality metrics and provide regular updates on quality events and investigation status to management.Support continuous improvement initiatives across manufacturing and quality operations.RequirementsBachelor's degree preferred.Minimum of 5+ years of Quality Assurance experience in pharmaceutical or biotech manufacturing.Strong GMP experience in a regulated manufacturing environment.Experience managing deviations, CAPAs, and OOS investigations.Demonstrated experience with root cause analysis, risk assessment, and investigation management.Experience supporting internal, customer, supplier, or regulatory audits.Experience working within a Quality Management System (QMS), including quality events, CAPAs, and related documentation.Strong technical writing, problem-solving, and cross-functional communication skills.Ability to manage complex investigations and drive quality issues through resolution.Preferred QualificationsExperience supporting API manufacturing or working with peptides, oligonucleotides, or other pharmaceutical products.Experience interacting with regulatory agencies, including the FDA, EMA, MHRA, or Health Canada.Familiarity with electronic QMS platforms such as Veeva or MasterControl.#LI-CS1