Quality Operations Specialist 503B (1st shift)

Empower Pharmacy; Houston (TX); On-site; USD 70,000 - 90,000; Full time

Job summary

Empower Pharmacy is seeking a Quality Operations Specialist in Houston, TX. This role involves ensuring product safety and regulatory compliance while overseeing quality processes. The company values commitment to excellence and offers comprehensive benefits, fostering a supportive workplace to drive innovation in healthcare.

Benefits

Medical coverage

Dental coverage

Vision coverage

401(k) matching

Paid time off

Wellness perks

Compounded medications

IV therapy

Qualifications

• Minimum of 4 years of directly related experience.
• Experience in sterile and nonsterile manufacturing.
• Knowledge of state and federal regulations.

Responsibilities

• Oversees manufacturing operations to ensure product sterility and safety.
• Reviews Good Manufacturing Practice batch records for accuracy.
• Conducts operational checks and compliance with environmental standards.

Skills

Attention to detail

Organizational skills

Problem-solving

Customer Focus

Collaboration

Education

Bachelor of Science in a science-related discipline

Tools

Microsoft Office

Job description

Quality Operations Specialist 503B (1st shift)

Location: Houston, Texas 77041, United States

Job Type: FULL TIME

Req# 4051

Quality

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.

What sets us apart is our relentless focus on four core values: People, Quality, Service and Innovation. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you’ll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let’s revolutionize healthcare, together. Join us and be a part of something extraordinary.

Position Summary

The Quality Operations Specialist plays a critical role in ensuring product safety, sterility, and regulatory compliance by overseeing quality processes, conducting thorough documentation reviews, and proactively identifying and resolving issues. Through meticulous attention to detail and adherence to industry standards, this position supports Empower’s mission to provide safe, effective, and affordable innovative medications, maintaining the highest level of quality in pharmaceutical production.

Duties and Responsibilities

• Oversees manufacturing operations to ensure product sterility, safety, and quality, monitoring personnel and processes with authority to halt operations if needed.
• Reviews Current Good Manufacturing Practice batch records and documentation for accuracy, ensuring compliance with procedures and standards.
• Initiates and assists in investigations to identify root causes, implement corrective actions, and resolve quality issues using problem-solving skills.
• Conducts operational checks on cleaning, labeling, and cleanroom layouts, ensuring compliance with environmental monitoring and documentation standards.
• Supports, monitors and assists safety, improvement initiatives, and environmental monitoring tasks, including gown qualification and media fill proctoring.

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

• Strong attention to detail, organizational, and prioritization skills, with the ability to multitask effectively while adhering to aseptic and regulatory standards.
• Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook) with required experience in sterile and nonsterile manufacturing and knowledge of state and federal regulations.

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 4 years of directly related experience.
• Bachelor of Science in a science-related discipline.

Employee Benefits, Health, and Wellness

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/ - Link Opens in New Tab