Quality Operations Specialist ; 2nd shift
Listed on 2026-01-01
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Quality Assurance - QA/QC
Quality Engineering
Quality Operations Specialist 503A (2nd shift)
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Position SummaryThe 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.
Dutiesand Responsibilities
- Oversee manufacturing operations to ensure product sterility, safety, and quality, monitoring personnel and processes with authority to halt operations if needed.
- Review Current Good Manufacturing Practice batch records and documentation for accuracy, ensuring compliance with procedures and standards.
- Initiate and assist in investigations to identify root causes, implement corrective actions, and resolve quality issues using problem‑solving skills.
- Conduct operational checks on cleaning, labeling, and cleanroom layouts, ensuring compliance with environmental monitoring and documentation standards.
- Support, monitor and assist safety, improvement initiatives, and environmental monitoring tasks, including gown qualification and media fill proctoring.
- 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.
- 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.
- 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.
- Minimum of 4 years of directly related experience.
- Bachelor of Science in a science‑related discipline.
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:
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