The Quality Control (QC) Investigation Writer is responsible for leading, authoring, and coordinating laboratory investigations within the Quality Control department in support of GMP-regulated pharmaceutical manufacturing operations.
Compensation
Pay Rate Range: $20.00 - $36.00/hr. on W2
Responsibilities
Lead and author Quality Control laboratory investigations related to Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, Environmental Monitoring (EM) excursions, laboratory deviations, atypical laboratory events, invalid assay and microbiological test results, data integrity and documentation discrepancies.
Collect, review, and analyze laboratory data, test methods, chromatograms, worksheets, instrument records, environmental monitoring data, and supporting documentation to determine probable root cause and product impact.
Facilitate investigation meetings with laboratory personnel and cross-functional stakeholders to gather facts, evaluate evidence, and develop scientifically justified conclusions.
Perform and document root cause analyses using established investigation tools and methodologies.
Prepare clear, concise, and comprehensive investigation reports that meet internal procedures, FDA expectations, and current GMP requirements.
Provide strategic and technical leadership for GMP analytical activities, managing method lifecycle, quality assurance, and regulatory compliance.
Compensation
The annual base pay (or hourly rate of compensation) for this position ranges from $135,463.20 to $203,194.80. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
Lead analytical method transfer, qualification, validation, verification, implementation, troubleshooting, lifecycle management, performance monitoring, continuous improvement, and retirement
Establish technical strategies for analytical readiness, including laboratory capability, instrumentation, materials, reference standards, reagents, methods, documentation, data systems, training, and external laboratory support
Provide technical oversight and scientific direction for complex laboratory investigations, out-of-specification and out-of-trend results, method-related deviations, and analytical risk assessments
Support quality records associated with analytical method lifecycle management, including deviations, CAPAs, change controls, and risk assessments
Serve as a key analytical technical interface across Quality Control functions, Analytical Development, Manufacturing, Quality Assurance, Process and Equipment Validation, Regulatory CMC, Supply Chain Planning, External Quality and Supply, and site and network partners
Lead and manage manufacturing operations at a single-use cell processing and biopharmaceutical manufacturing site, owning P&L, driving continuous improvement, and ensuring compliance with regulatory standards.
Responsibilities
Lead all site manufacturing operations to ensure safe, compliant, reliable, and profitable execution of customer demand.
Own site P&L performance, including revenue attainment, EBITDA, gross margin, labor and overhead management, productivity, spending, savings, and budget execution.
Develop and execute the site operating plan and manufacturing strategy in alignment with company objectives, customer demand, and growth priorities.
Direct manufacturing execution, facilities, maintenance, and continuous improvement activities to achieve Safety, Quality, Delivery, Cost, and People objectives.
Ensure effective utilization of labor, equipment, materials, information, and facility capacity to improve throughput, yield, lead time, asset utilization, and on-time delivery.
Requirements
Bachelor's degree in engineering, operations, business, life sciences, or a related field
Nice to have: Lean Six Sigma certification
Nice to have: Cleanroom manufacturing
Nice to have: Experience supporting biopharmaceutical customers
