Quality Engineer

Quality Engineer at Link Pharmacy Quality Engineer at Link Pharmacy in Denton, Texas Posted in 3 days ago.

Type:

full-time

Job Description:

About the Company Reports To Quality Director of Operations About the Role The Quality Engineer - Sterile Compounding is responsible for maintaining and improving the Quality Management System (QMS) within a 503A sterile compounding pharmacy in compliance with

USP, FDA

expectations, and applicable state regulations. This role expands beyond traditional QA Specialist responsibilities to include equipment qualification (IQ/OQ/PQ), process validation, environmental control strategy, and continuous process improvement. The Quality Engineer ensures that sterile compounding operations are scientifically controlled, validated, and inspection-ready at all times. Responsibilities Support and maintain elements of the Quality Management System (QMS) Author, revise, and execute technical operations (IQ/OQ/PQ) protocols, and technical reports Ensure USP procedures are scientifically sound and effectively implemented Lead deviation, investigation, and CAPA processes with a risk-based approach Perform quality risk assessments (FMEA, risk ranking, etc.) Analyze and trend quality data (EM, deviations, complaints, audit findings) Support internal audits, gap assessments, and regulatory inspections (FDA, State Boards) Lead and execute equipment qualification lifecycle: Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Develop and approve qualification protocols and reports for: Cleanroom HVAC systems with HEPA filtration systems Laminar airflow workbenches (LAFW), BSCs (Biological Safety Cabinets) Temperature mappings Critical compounding equipment (autoclave and oven) Ensure calibration and preventive maintenance programs are effective Support cleanroom certification reviews and requalification activities Design and execute process validation strategies for sterile compounding Lead aseptic process simulations (media fills) and requalification programs Develop validation protocols including: Worst-case conditions Process challenge studies Hold time studies Evaluate process capability and variability Ensure validated state is maintained through lifecycle monitoring Oversee viable and non-viable environmental monitoring program Perform trend analysis and statistical evaluation of EM data Establish alert/action levels and contamination control strategies Lead investigations into EM excursions and implement corrective actions Support contamination control strategy (CCS) aligned with USP Lead root cause investigations using structured methodologies (5 Whys, Fishbone, etc.) Develop and implement effective CAPAs Monitor CAPA effectiveness and closure timelines Identify process improvement opportunities using data and trends Drive continuous improvement initiatives across sterile operations Ensure personnel qualification programs are compliant and effective: Aseptic technique qualification Media fill certification Gowning qualification Visual inspection and labeling qualification program Support development of training materials and technical instruction Evaluate operator performance and requalification needs Review and approve Certificates of Analysis (COAs) Support supplier qualification and risk assessment Ensure incoming materials meet sterile compounding requirements Participate in vendor audits and quality agreements Qualifications - Required Bachelor's degree in Engineering, Life Sciences, or related field 5+ years experience in sterile compounding, pharmaceutical quality, or regulated environment Strong knowledge of USP and aseptic processing principles Experience with equipment qualification (IQ/OQ/PQ) and/or process validation Knowledge of quality systems, investigations, and CAPA Qualifications - Preferred Experience in GMP regulated industry and/or aseptic sterile operations Familiarity with USP Experience with cleanroom design and contamination control strategy Exposure to FDA inspections or regulatory audits Lean/Six Sigma or quality certification (ASQ CQE, CQA, etc.) Skills & Competencies Strong technical writing (protocols, reports, investigations) Analytical thinking and problem-solving capability Ability to interpret data and apply statistical tools Attention to detail with strong compliance mindset Cross-functional collaboration and communication Proficiency in Excel and quality management systems Working Conditions Work in ISO-classified cleanroom environments Required gowning and aseptic practices Combination of desk-based analysis and floor support Occasional lifting and standing in controlled environments Key Performance Indicators (KPIs) Equipment qualification on-time completion (IQ/OQ/PQ) Process validation success and state of control Environmental monitoring trend performance Deviation and CAPA closure effectiveness Inspection readiness and audit outcomes Training and qualification compliance rates