Quality Assurance Compliance Specialist

ConsultantPharmaceutical Industries Ltd.Salt Lake City, UT 84108 — 575 South Chipeta Way100% OnsiteMonday–Friday, 8:00 AM–5:00 PM2 YearsContract, No Temp-to-Perm5+ years minimum; 7 years relevant progressive experience preferred/required with equivalent education/experience.Job SummaryWe are seeking a Compliance Specialist III to support Quality Compliance activities within a pharmaceutical manufacturing environment. The role will oversee site compliance programs, inspection readiness, internal and external audits, quality metrics, Quality Technical Agreements, investigations, CAPA activities, knowledge management, and supplier/vendor qualification. The ideal candidate will have strong GMP/cGMP Quality Systems and Regulatory Compliance experience, excellent technical writing and documentation skills, and the ability to work independently while collaborating with Quality, Operations, suppliers, and other cross-functional teams.Key ResponsibilitiesManage Quality Compliance Oversight and site quality system activities.Support Quality Council / Management Review forums and communicate site quality status.Develop and monitor site compliance metrics.Manage Quality Technical Agreements (QTA) with internal and external partners.Lead and execute internal GMP audits.Coordinate external audits and regulatory inspections, including responses and CAPA tracking.Manage the site's Inspection Readiness Program.Support CAPA, investigations, corrective action plans, and compliance issue resolution.Conduct regulatory reviews, gap assessments, and Knowledge Management activities.Manage supplier/vendor qualification and compliance activities.Perform periodic document reviews and compliance gap assessments.Own and update SOPs/procedures for assigned responsibilities.Lead cross-functional compliance projects and present findings to senior management.Collaborate with Site Operations and Quality Management to resolve compliance issues.Required QualificationsBachelor's degree, preferably in Science or Engineering, or equivalent combination of education and experience.Minimum 7 years of relevant progressive experience in pharmaceutical or related industry, or equivalent combination.Strong experience with GMP Quality Systems and regulatory compliance.Experience with internal/external audits and inspection readiness.Experience with CAPA, investigations, and compliance issue resolution.Quality documentation review/approval and Quality Technical Agreements experience.Strong technical writing, communication, analytical, and problem-solving skills.Ability to work independently and make decisions in complex situations.Pharmaceutical manufacturing/cGMP environment experience is preferred.Preferred Qualifications3+ years performing GMP Quality System audits/measurements.Regulatory inspection support experience.Experience writing/negotiating Quality Technical Agreements.ASQ CQE/CQA or equivalent certification.Experience with FDA, EMA, DEA, EPA and other applicable regulatory requirements.Systems / Technical SkillsExperience with:SAP / OracleLIMSTrackWiseVeevaQdocsLearning Management Systems (LMS)Microsoft OfficePharmaceutical Quality Management SystemsThe Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.