QA/QC Consultant

QA Consultant – Quality Assurance (QC Support)Candidate Deck: QA/QC Consultant Candidate DeckPioneer GMP Consulting partners with pharmaceutical, biotech, and CDMO organizations to deliver technical expertise across GMP-regulated environments. As demand continues to grow—particularly across North Carolina and the Research Triangle—we are expanding our team of Quality Assurance consultants who support laboratory and QC-focused initiatives.We are looking to connect with experienced QA professionals who want to be part of a true consulting team—working alongside Pioneer leadership and other consultants to support meaningful, high-impact projects across the life sciences industry.Our consultants represent Pioneer on client engagements, providing QA oversight and support across laboratory operations, analytical methods, and quality systems.What You’ll SupportWe work with clients across a range of technical and operational disciplines, including:Our QA consultants play a critical role in ensuring quality and compliance across QC and laboratory functions. Typical responsibilities include:Laboratory Investigations & QA ReviewQuality review and approval of laboratory investigations, including:Out of Specification (OOS)Out of Trend (OOT)Atypical resultsLaboratory deviations and nonconformancesSupport root cause investigations, impact assessments, and CAPAsChange Control & Documentation OversightProvide QA oversight of change controls related to:Laboratory methodsInstrumentationSpecifications and proceduresReview and approve controlled GMP documentation, including:SOPs, forms, specifications, protocols, and reportsSupport document control and change control implementation activitiesAnalytical Methods & ValidationProvide QA oversight across the analytical method lifecycle, including:Method qualification, validation, verification, and transferReview and approve validation and qualification protocols, reports, and supporting documentationSupport phase-appropriate implementation of analytical methods, including cell therapy testingEquipment & Systems Quality SupportProvide QA support for laboratory equipment qualification activities:IQ/OQ/PQ documentation reviewCalibration and maintenance record reviewPeriodic lifecycle documentation reviewTypical Client ProjectsOur QA consultants support initiatives such as:Laboratory startup and expansion effortsAnalytical method validation and transfer programsInvestigation remediation and CAPA effectiveness improvementsQuality system enhancements and inspection readinessCell and gene therapy program supportWho We’re Looking ForSuccessful consultants typically bring:Experience working in GMP-regulated pharmaceutical, biotech, or CDMO environmentsBackground supporting manufacturing, engineering, validation, quality, or technical operations5+ years of Quality Assurance experience in GMP-regulated pharmaceutical or biotech environmentsExperience supporting QC laboratories and analytical testingStrong experience with investigations, change controls, and GMP documentationFamiliarity with cell therapy, gene therapy, or biologics (preferred)A willingness to travelBachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, or related scientific disciplineStrong communication, collaboration, and problem-solving skillsWorking knowledge of:cGMP regulations (21 CFR Parts 210, 211; familiarity with 1271 preferred)ICH Q2About Pioneer GMP ConsultingAt Pioneer GMP Consulting, our consultants are an extension of our clients’ teams—helping organizations solve complex challenges across manufacturing, quality, engineering, and compliance.We focus on building long-term relationships with experienced professionals, connecting them with meaningful projects while providing the support of a collaborative consulting team.If you’re interested in learning more about Pioneer and the types of QA/QC-focused projects we support, we’d welcome the opportunity to connect.