Quality Control

• Conduct chemical and physical laboratory tests and analysis on products and raw materials
• Make judgments on quality and report results
• Assist with special projects in accordance with GMP and safe food/safe feed policies
• Perform chemical, physical, and microbiological testing of raw materials, in-process samples, and final products
• Support product quality, regulatory compliance, and continuous improvement initiatives through accurate testing, documentation, and equipment maintenance
• Utilize safe work habits and follow all policies and procedures
• Maintain a clean lab environment and perform necessary calibrations on lab equipment
• Participate in internal audits, regulatory inspections, and laboratory assessments
• Support change controls, deviations, CAPAs, method validations, and method transfers
• Analyze samples to determine chemical and physical characteristics and evaluate conformity
• Prepare chemical solutions, reagents, media, samples, and standards
• Confirm incoming samples are properly labeled and correct tests have been requested
• Record test data and perform required calculations
• Maintain written records, databases, and hardcopy files in compliance with ALCOA+ data integrity principles
• Review test results and supporting documentation for completeness and accuracy
• Ensure proper archival and retention of laboratory records
• Maintain confidentiality of methods, analyses, and results
• Investigate out-of-specification, out-of-trend, and atypical results
• Calibrate, operate, maintain, troubleshoot, and perform routine maintenance on laboratory equipment
• Assist in ordering lab supplies
• Organize documents, samples, and pertinent records
• Collaborate with other departments to accomplish tasks and goals
• Suggest and implement process improvement, cost-down, and best-practice ideas
• Complete 5S activities and support laboratory investigations and special projects

Quality Control Lab Technician

• Lead, coach, and mentor the independent inspection team
• Set goals, conduct performance reviews, and address performance or conduct concerns through approved processes
• Manage schedules, attendance, paid time off, coverage, and handoffs within delegated authority
• Support recruiting, onboarding, staffing, and formal personnel actions with the Quality Manager and P&C
• Prioritize inspection work based on approved priorities, product risk, and need dates
• Rebalance qualified resources and monitor queue aging, holds, blocked work, and coverage risks
• Ensure inspections use approved requirements, qualified personnel, calibrated equipment, and complete, traceable records
• Supervise receiving, in-process, component, wire-harness, final, source, customer, and Government inspections
• Ensure Certificates of Conformance and shipment-release records use approved requirements and templates
• Approve records or release conforming product within documented qualification and delegated authority
• Stop inspection or prevent release when requirements or evidence are inadequate
• Place and remove Quality holds, initiate nonconformance records, coordinate containment, and escalate disposition or waiver decisions
• Own onboarding, training, qualification, and cross-training for Quality Control Inspectors
• Verify competency and coordinate technical content with Quality Engineers or subject-matter experts
• Own inspection performance metrics and reporting, including backlog aging, completion to need date, hold aging, coverage, qualifications, inspection errors, and reinspection
• Use inspection data to identify risks and improvement priorities
• Lead approved improvements to standard work, visual controls, work areas, and workload management
• Coordinate with affected functions to support product flow while preserving independent Quality decisions and acceptance requirements
• Support QMS and audit activities affecting the team
• Ensure compliance with applicable Quality, safety, ESD, FOD, workmanship, and product-handling requirements
• Identify deficiencies and implement approved improvements with managerial support
• Perform other duties and responsibilities as needed

Quality Control Supervisor

• Review production records, quality records and training records daily for accuracy
• Take product samples at various processing stages
• Conduct routine tests against product specifications
• Perform data entry, record keeping, filing and document management, including RMA, CRR, End of Shift and MRB records
• Verify raw-material and finished-goods dimensions using measuring instruments
• Inspect products and packaging for basic quality defects and verify data accuracy and completeness
• Conduct quality audits and assist in developing quality management and quality assurance standards
• Support production teams in identifying, containing and correcting production-line quality issues
• Review RGA tags and record RGAs in the RGA Log
• Schedule and execute sample testing, document findings and provide initial data analysis
• Coach employees when quality defects are identified
• Keep the Quality Supervisor informed of situations compromising quality or deviating from standards
• Inform management about non-conforming materials, products or processes
• Interact with peers, Group Lead, Group Manager, Production Manager, HSE Manager, Human Resources, Quality, JEM and Plant Manager
• Report to the Quality Supervisor

Quality Control Inspector

• Lead and supervise a team of 6–12 QC Micro analysts
• Manage scheduling, training, performance feedback, career development, and team qualification matrices
• Oversee environmental monitoring and utility programs, including viable/non-viable monitoring, compressed gases, WFI/PW, and clean steam
• Ensure timely and compliant execution of compendial and in-house microbiology methods
• Review and approve data, test records, LIMS entries, and COAs while ensuring ALCOA+ data integrity
• Manage sample logistics, inventory, and equipment readiness, including calibration and preventive maintenance
• Lead or approve QC Micro deviations, OOS/OOT investigations, environmental monitoring excursions, and product impact assessments
• Author and implement CAPAs and change controls
• Contribute to risk assessments, trend reports, stability/annual product review inputs, and APR/PQR
• Maintain and improve SOPs, methods, and validation/qualification documents
• Partner with Manufacturing, Validation, and Facilities on contamination control, cleanroom behavior, gowning, cleaning/disinfection, and aseptic interventions
• Support media fills, aseptic qualifications, and Annex 1 compliance initiatives
• Drive throughput, right-first-time, and turnaround-time improvements using Lean/Six Sigma tools
• Support or lead rapid microbiology method implementation, LIMS/ELN upgrades, and equipment qualifications (URS, IQ/OQ/PQ)
• Ensure compliance with FDA/EMA/PMDA/MHRA, USP/EP/JP, ICH, and EU Annex 1 requirements
• Host or support internal/external audits and maintain an inspection-ready laboratory

Quality Control Supervisor, Microbiology

• Receive, log, label, route, and track raw material, in-process, stability, and finished-product samples and associated documentation
• Maintain QC sample records, stability schedules, trackers, dashboards, and controlled laboratory data; enter and trend/graph data
• Archive, retrieve, organize, and reconcile analytical documentation and laboratory records
• Coordinate external testing, including sample preparation, shipment documentation, status follow-up, and filing of results
• Manage reference materials, standards, reagents, retained samples, and laboratory consumables, including inventory monitoring and ordering support
• Support peptide and material disposition activities by compiling records, performing approved calculations, and routing documentation for review
• Support generation, revision, review routing, and maintenance of QC documentation, including SOPs, forms, training records, deviations, change controls, and out-of-specification documentation
• Coordinate sampling and testing activities with Quality Control, Quality Assurance, Production, and other departments; communicate status and potential issues
• Maintain assigned QC equipment and work areas; assist with equipment records, service coordination, and calibration status tracking
• Support special projects, regulatory or customer requests, and continuous-improvement activities, including QC dashboard development

Quality Control Technician

• Perform testing and/or auditing to ensure products are manufactured and shipped according to company specifications
• Assist with problem solving related to product quality and identify areas for improvement
• Support implementation of effective quality solutions
• Follow Food Safety, Quality, and GMP procedures and requirements
• Monitor and collect qualitative and quantitative product data and enter analytical data into the computerized lab management system
• Maintain a clean and safe work environment
• Maintain and calibrate test equipment according to schedule
• Follow lab standard operating procedures and methods
• Troubleshoot manufacturing issues, including risk assessments, deviations, retesting, and raw-material and finished-goods rejections
• Monitor and approve production equipment sanitation, startup, and performance
• Monitor the plant environment using test equipment and procedures
• Routinely monitor production lines and operator checks throughout production auditing
• Monitor plant GMPs and quality and food safety programs through assigned audits and corrective actions
• Support technical communication in shift meetings and with cross-functional shift team members
• Investigate, test, and collect data to improve processes or products and packaging
• Support technical, quality and food safety, continuous improvement, cost reduction, and R&D projects
• Contribute to a positive team culture and promote servant leadership
• Establish and work toward personal development objectives

• Perform routine and advanced microbiological analysis of raw materials, finished goods, packaging components, and complaint/investigation samples
• Conduct environmental monitoring while maintaining aseptic practices
• Collect and analyze environmental and utility samples
• Record, calculate, interpret, and report microbiological test results
• Support product and process validation, product release, and regulatory compliance
• Own and revise SOPs and ATPs
• Execute investigative testing and support laboratory investigations
• Perform peer review of data
• Train team members on microbiological methods and laboratory practices
• Ensure GDP, GMP, and GxP-compliant documentation
• Operate, maintain, and troubleshoot laboratory instrumentation
• Collaborate cross-functionally to support manufacturing and integrate laboratory results
• Use LIMS, TrackWise, and Metasys

Associate I, Quality Control Lab – Microbiology

• Perform daily analytical testing and evaluation of raw materials, work-in-process (WIP), and finished goods
• Use laboratory methods including gas chromatography (GC), high-performance liquid chromatography (HPLC), spectrophotometry, titration, wet chemistry, gravimetric, and organoleptic/sensory techniques
• Conduct routine maintenance, calibration, and basic troubleshooting of assigned laboratory equipment and analytical instruments
• Evaluate test results and determine conformance with quality standards, specifications, and procedures
• Maintain inventory-management processes, including production-related inventory movements, material quantities consumed, documentation, and storage practices
• Follow company, quality, safety, environmental, and corporate policies and procedures
• Communicate quality-related findings, concerns, and results to appropriate departments
• Perform additional duties as assigned
• Work primarily in a laboratory and manufacturing environment while complying with environmental, health, and safety requirements

• Inspect component parts and completed products for conformance to process controls using visual inspection and measuring tools
• Perform final inspection tasks on switches and parts being shipped
• Train production personnel in effective process-control methods
• Perform internal process audits and report findings
• Shut down non-conforming processes after notifying the Supervisor
• Communicate drawing discrepancies to Engineering
• Participate in customer inspections as needed
• Assist with preparing and entering NCRs (Non-Conformance Reports)
• Write Customer Improvement Initiatives (CII) for audits and assist with corrective-action reporting
• Report ISO-standard violations to the Quality Manager
• Participate in prototype reviews for newly developed products
• Assist in dimensional analysis of components to identify potential quality issues
• Help create and implement process control charts for critical processes
• Maintain a safe and clean working environment
• Use equipment and supplies efficiently
• Train team members in inspection tasks as needed
• Inspect work before passing it to the next operation
• Complete production and quality documentation

Quality Control Inspector I – 2nd Shift

• Conduct physical evaluations of final products, intermediate products, raw materials, incoming materials, and existing inventory
• Perform GMP inspections
• Assist in validation studies
• Prepare instrumentation and chemical solutions for Quality department use
• Evaluate raw materials, manufacturing components, batch formulations, and finished products against QC specifications and GMP requirements
• Inspect products produced and assembled in operations areas and inspect the Manufacturing area for GMP compliance
• Analyze test results against established specifications
• Complete paperwork and records for all aspects of the job
• Assist in creating and developing product standards, testing methods, and standard operating procedures
• Maintain a clean and safe environment
• Perform other duties as assigned