Quality Engineer - Pharmacy Operations

Gifthealth Inc • Columbus, OH

5d • $88,000 - $112,000 • Onsite

About The Position

About Us
At Gifthealth, we're revolutionizing the way people experience healthcare by simplifying the process of managing prescriptions and health services. Our mission is to provide a seamless, personalized, and efficient healthcare experience for all our customers. We're a dynamic, innovative, and customer-centric company dedicated to making a positive impact on people's lives.

Position Summary
The Quality Engineer is responsible for supporting and maintaining quality systems within a pharmacy environment, with a strong focus on equipment qualification, process validation, environmental monitoring, and cold chain quality oversight. The ideal candidate has hands-on experience with IQ/OQ/PQ, process validation, environmental monitoring, and cold chain shipping in regulated and distribution operations, and is comfortable driving investigations, risk assessments, CAPAs, and continuous improvement activities.

Requirements

• Bachelor’s degree in engineering, Quality, Microbiology, Chemistry, Lifesciences, or a related technical field.
• 3-7 years of experience in a regulated environment
• Demonstrated experience with IQ/OQ/PQ for equipment, systems, and/or facilities.
• Strong experience in process validation and with automated equipment within a regulated manufacturing setting.
• Hands-on experience supporting or managing environmental monitoring programs in controlled environments.
• Experience supporting cold chain shipping, storage, and distribution quality activities, preferably for temperature-sensitive pharmaceutical or healthcare products.
• Working knowledge of regulations and guidance applicable to manufacturing, validation, and distribution activities.
• Experience with deviation investigations, CAPA, change control, and risk assessments.
• Strong technical writing skills, with experience authoring protocols, reports, validation documents, and quality procedures.
• Ability to analyze data, identify trends, and make sound quality-based decisions.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Support and oversee qualification and validation activities for facilities, utilities, equipment, and dispensing processes in accordance with regulatory requirements.
• Define validation scope, approach, responsibilities, acceptance criteria, and requalification/revalidation strategy for facilities, utilities, equipment, processes, and computerized systems as applicable.
• Develop, review, execute, and approve validation lifecycle documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and process validation protocols and reports.
• Ensure qualification and validation activities are scientifically sound, risk-based, and compliant with internal procedures and regulatory expectations.
• Support ongoing process validation and continued process verification activities through data collection, trending, and analysis.
• Review and trend process performance data to identify risks, deviations, and opportunities for improvement.
• Manage or support the environmental monitoring program for classified or controlled manufacturing areas, including viable and non-viable monitoring review, trending, excursion assessment, and follow-up actions.
• Investigate environmental monitoring excursions, nonconformances, and deviations, support root cause analysis and effectiveness checks for corrective and preventive actions.
• Author, review, and revise SOPs, work instructions, protocols, and technical reports related to quality engineering, validation, monitoring, and distribution quality activities.
• Participate in change control assessments related to equipment, processes, manufacturing areas, utilities, monitoring systems, and distribution processes.
• Partner with the Gifthealth Supply Chain team to support quality requirements for storage, handling, packaging, and distribution of temperature-sensitive materials and products.
• Provide quality oversight for cold chain shipping processes, including shipper qualification, packaging configuration review, temperature monitoring requirements, lane assessments, and excursion management.
• Support development, implementation, and continuous improvement of procedures and controls for cold chain distribution to ensure product quality and compliance are maintained throughout transport.
• Review and assess temperature excursion events, support investigations, perform risk assessments, and help define appropriate corrective and preventive actions.
• Collaborate with internal stakeholders and external logistics partners to ensure compliant cold chain practices and documentation.
• Support internal and external audits and regulatory inspections by providing documentation, technical rationale, and subject matter expertise.
• Collaborate with site teams to ensure compliance with GMP, data integrity, contamination control, quality risk management principles, and applicable distribution requirements.
• Drive continuous improvement initiatives that enhance product quality, process robustness, distribution reliability, and operational compliance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level