Quality Assurance Specialist with Clinical and Commercial distribution operations
Job Title: Quality Assurance SpecialistLocation: Louisville, KY 40258 (Hybrid)Employment Type: W2 Contract – 12 Months with possible extensionsPay Rate: $38.00 – $40.00/hour (determined by experience)Schedule: Monday – Thursday | 8:00 AM – 4:30 PMRemote Fridays: 8:00 AM – 4:30 PMNote: This is a W2 only role — C2C and C2H candidates will not be considered.Role Overview:BEPC is seeking an experienced Quality Assurance Specialist to support Clinical and Commercial distribution quality operations in Louisville, KY. This role focuses on GMP/GDP quality oversight, regulatory compliance, transportation quality management, and distribution quality activities supporting clinical and commercial pharmaceutical products.The ideal candidate will have experience in regulated pharmaceutical, biotech, or medical device environments and possess strong knowledge of GMP/GDP operations, quality systems, and regulatory compliance processes.Key Responsibilities:Manage quality activities supporting Clinical and Commercial PT distribution and in-country GMP/GDP operationsSupport regulatory readiness activities to ensure a compliant supply of clinical and commercial materialsProvide quality oversight for:Artworks operationsLaunchesVariations and renewalsIMP flowchartsManage GMP documentation and ensure compliance with IND/QIMPD requirementsProvide quality oversight of transportation activities including:Planned eventsUnplanned eventsProduct quality impact assessmentsSupport quality oversight activities across:Transport providersWarehousing and distribution centersExternal partnersContract manufacturing organizations (CMOs)In-country testing laboratoriesSupport customer engagement activities including:Customer complaint intakeComplaint investigations and responsesDeployment of customer-focused quality solutionsBuild and support Quality capabilities within Distribution Quality and Country Quality Network operationsIdentify and drive continuous improvement initiatives based on:Customer needsRegulatory requirementsIndustry trendsOperational performance metricsEnsure audit and inspection readiness for GMP/GDP distribution operationsSupport implementation of Quality requirements within the Pharmaceutical Quality System (PQS)Release, reject, or quarantine:Clinical materialsIMP productsCommercial medicinal productsMedical devicesSupport product disposition activities in compliance with cGMP and internal quality standardsQualifications:Bachelor’s degree in:Life SciencesQualityEngineeringRelated scientific discipline preferredExperience in:Pharmaceutical quality assuranceGMP/GDP operationsDistribution qualityRegulated environmentsStrong knowledge of:cGMPGDP requirementsRegulatory compliancePharmaceutical quality systemsExperience supporting:AuditsInspectionsQuality documentationProduct disposition activitiesStrong analytical, organizational, and communication skillsAbility to work independently and collaboratively in cross-functional teamsStrong attention to detail and problem-solving abilitiesPreferred Qualifications:Experience with:Clinical supply distributionCommercial pharmaceutical distributionTransportation quality oversightComplaint handling processesFamiliarity with:Swissmedic requirementsIND/QIMPD documentationIMP operationsExperience supporting continuous improvement initiatives and quality metricsWork Environment:Hybrid schedule: Onsite Monday–ThursdayRemote FridaysCross-functional pharmaceutical quality environmentFast-paced regulatory and distribution operations settingMultiple interview rounds requiredAbout BEPC:BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.Apply Now!Qualified candidates are encouraged to apply by submitting an up-to-date resume highlighting experience with GMP/GDP quality operations, pharmaceutical quality systems, distribution quality oversight, and regulatory compliance. Please include specific examples demonstrating quality assurance expertise, audit readiness support, and cross-functional collaboration.Benefits:Dental insuranceHealth insuranceLife insuranceVision insuranceEducation:Bachelor's (Required)Experience:Pharmaceutical quality assurance: 3 years (Required)GMP/GDP operations & Distribution Quality: 3 years (Required)Audits, Inspections & Quality documentation: 3 years (Required)