Empower Pharmacy
Location: East Windsor, New Jersey 08520, United States
Posted:
September 18, 2025 Job Type:
FULL TIME Req#
5135 Company Overview
Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets. Our four core values are People, Quality, Service and Innovation. We collaborate to break new ground in manufacturing, distribution and quality control, leveraging vertical integration, state‑of‑the‑art technology, and a commitment to excellence to improve medication accessibility and affordability. We invite you to join a mission-driven team where you can innovate, grow, and contribute to meaningful projects. We offer a supportive and engaging workplace that recognizes and celebrates your contributions. Let’s revolutionize healthcare, together. Position Summary
The Senior Quality Engineer ensures compliance with compounding practices, United States Pharmacopeia (USP), Food and Drug Administration (FDA) standards, and Current Good Manufacturing Practice (cGMP). This role leads process validation, investigates deviations, implements Corrective and Preventive Actions (CAPAs), supports product tech transfers, and drives continuous improvement to maintain audit readiness and enhance quality management systems. Duties And Responsibilities
Ensure compliance with compounding practices, USP, FDA standards, and cGMP through audits, inspections, and evaluation of deviations, complaints, supplier management, and CAPAs. Lead validation of compounding processes and documentation in alignment with cGMP, serving as the primary technical reviewer for change controls and quality records. Investigate quality deviations and complaints, implementing CAPAs through root cause analysis, and partner with internal teams to improve quality management systems and provide cGMP, data integrity, and compliance training. Review and approve product tech transfer validation protocols, change controls, and quality records in the electronic document control system while analyzing data to drive continuous improvement. Develop team capabilities through training, lead risk assessments, and ensure audit readiness by proactively addressing quality issues. Note: The role includes typical office and facility movement and use of computer and office productivity devices. Knowledge And Skills
Extensive expertise in compendial testing, FDA regulatory requirements, cGMP standards, and experience managing product complaints, deviations, CAPAs, document control, and change control within pharmaceutical and medical device environments. Strong background in sterile and aseptic drug manufacturing, including cGMP regulations, USP, and 21 CFR Parts 210, 211, and 11, with proficiency in process improvement tools (e.g., Six Sigma, lean manufacturing), Microsoft Office, and data analysis using Excel or Minitab. Key Competencies
Customer Focus Optimizes Work Processes Collaborates Resourcefulness Manages Complexity Ensures Accountability Situational Adaptability Communicates Effectively Values
People Quality Service Innovation Experience and Qualifications
Minimum of 5 years of experience in the pharmaceutical industry, including qualification protocols, validations, and root cause analysis. Bachelor’s degree in a science or engineering technical field. Employee Benefits, Health, and Wellness
We offer comprehensive benefits to support health and well-being, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: careers.empowerpharmacy.com/benefits/ Note: This description may include additional location-based postings for related roles.
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September 18, 2025 Job Type:
FULL TIME Req#
5135 Company Overview
Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets. Our four core values are People, Quality, Service and Innovation. We collaborate to break new ground in manufacturing, distribution and quality control, leveraging vertical integration, state‑of‑the‑art technology, and a commitment to excellence to improve medication accessibility and affordability. We invite you to join a mission-driven team where you can innovate, grow, and contribute to meaningful projects. We offer a supportive and engaging workplace that recognizes and celebrates your contributions. Let’s revolutionize healthcare, together. Position Summary
The Senior Quality Engineer ensures compliance with compounding practices, United States Pharmacopeia (USP), Food and Drug Administration (FDA) standards, and Current Good Manufacturing Practice (cGMP). This role leads process validation, investigates deviations, implements Corrective and Preventive Actions (CAPAs), supports product tech transfers, and drives continuous improvement to maintain audit readiness and enhance quality management systems. Duties And Responsibilities
Ensure compliance with compounding practices, USP, FDA standards, and cGMP through audits, inspections, and evaluation of deviations, complaints, supplier management, and CAPAs. Lead validation of compounding processes and documentation in alignment with cGMP, serving as the primary technical reviewer for change controls and quality records. Investigate quality deviations and complaints, implementing CAPAs through root cause analysis, and partner with internal teams to improve quality management systems and provide cGMP, data integrity, and compliance training. Review and approve product tech transfer validation protocols, change controls, and quality records in the electronic document control system while analyzing data to drive continuous improvement. Develop team capabilities through training, lead risk assessments, and ensure audit readiness by proactively addressing quality issues. Note: The role includes typical office and facility movement and use of computer and office productivity devices. Knowledge And Skills
Extensive expertise in compendial testing, FDA regulatory requirements, cGMP standards, and experience managing product complaints, deviations, CAPAs, document control, and change control within pharmaceutical and medical device environments. Strong background in sterile and aseptic drug manufacturing, including cGMP regulations, USP, and 21 CFR Parts 210, 211, and 11, with proficiency in process improvement tools (e.g., Six Sigma, lean manufacturing), Microsoft Office, and data analysis using Excel or Minitab. Key Competencies
Customer Focus Optimizes Work Processes Collaborates Resourcefulness Manages Complexity Ensures Accountability Situational Adaptability Communicates Effectively Values
People Quality Service Innovation Experience and Qualifications
Minimum of 5 years of experience in the pharmaceutical industry, including qualification protocols, validations, and root cause analysis. Bachelor’s degree in a science or engineering technical field. Employee Benefits, Health, and Wellness
We offer comprehensive benefits to support health and well-being, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: careers.empowerpharmacy.com/benefits/ Note: This description may include additional location-based postings for related roles.
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