Job Description

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:
Ensures compliance with compounding practices, USP, FDA standards, and cGMP through audits, inspections, and evaluations of deviations, complaints, supplier management, and CAPAs. Leads validation of compounding processes and documentation in alignment with cGMP, serving as the primary technical reviewer for change controls and quality records. Investigates quality deviations and complaints, implementing CAPAs through root cause analysis, and partners with internal teams and stakeholders to improve quality management systems and provide cGMP, data integrity, and compliance training. Reviews and approves product tech transfer validation protocols, change controls, and quality records in the electronic Document Control System while analyzing data to drive continuous improvement. Develops team capabilities through training, leads risk assessments, and ensures audit readiness by proactively addressing quality issues.


While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.
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 <795>, <797>, <800>, and 21 Code of Federal Regulations 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: Ability to build strong customer relationships and deliver customer centric solutions. Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement. Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives. Resourcefulness: Secures and deploys resources effectively and efficiently. Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems. Ensures Accountability: Holds self and others accountable to meet commitments and objectives. Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations. Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Values

People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth. Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce. Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service. Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

Experience and Qualifications:
Minimum of 5 years of experience in the pharmaceutical industry, including qualification protocols, validations, and root cause analysis required. Bachelor's degree in a science or engineering technical field.

Benefits:

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/