Quality Engineer - Pharmacy Operations

Description

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.

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.

• 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.

• Education: Bachelor’s degree in engineering, Quality, Microbiology, Chemistry, Lifesciences, or a related technical field.
• Experience: 3-7 years of experience in a regulated environment 
• Skills:  
  • 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.

• Location: [On-site]
• Schedule: [Full-time]
• Ability to work in a manufacturing environment, including controlled or classified areas.
• May require gowning and adherence to cleanroom procedures.
• Ability to stand, walk, and perform routine site-based activities as needed.

Gifthealth is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, national origin, age, disability, veteran status, or any other legally protected status.

This job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, or skills required of personnel.Gifthealth reserves the right to modify job duties or descriptions at any time.