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Pharmacy Quality Control Specialist

4 months ago

Houston, United States ReviveRX Full time

**Job Summary**:
Join our forward-thinking team as a Quality Control Specialist, where your expertise will be pivotal in advancing our commitment to excellence within a cleanroom sterile environment. Your role will be critical in managing samples, overseeing Quality Record Events (QRE), spearheading investigations, and formulating effective Corrective and Preventive Action (CAPA) strategies. As a key player in our quality assurance framework, you will ensure our products and services not only comply with but surpass regulatory benchmarks and customer expectations.

**Core Responsibilities**:
**Sample Management**:

- Employ expert aseptic techniques to collect samples throughout the sterile compounding process within a cleanroom setting.
- Organize and manage samples with precision outside of the cleanroom.
- Supervise the maintenance of equipment (e.g., incubators) to guarantee the integrity and timely analysis of sample incubation.

**Quality Records Events (QRE)**:

- Direct the identification, documentation, and thorough analysis of QREs to enhance quality control measures.

**CAPA Plan Development and Implementation**:

- Craft and execute detailed CAPA plans to rectify identified quality concerns, ensuring robust preventive measures.
- Lead cross-functional teams in the implementation of CAPA plans, ensuring widespread adherence and integration.
- Conduct comprehensive follow-ups to assess and confirm the effectiveness of implemented CAPA strategies.
- Demonstrable experience and proficiency in aseptic technique and sample management, ideally within the pharmaceutical or healthcare industry.
- Prior experience working in sterile environments, especially within sterile cleanrooms in a 503a or 503b pharmacy setting, is highly desirable.
- Deep knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other critical regulatory standards.
- Exceptional analytical, problem-solving, and decision-making skills.
- Strong interpersonal and communication abilities, with a track record of successful cross-departmental collaboration.
- A meticulous and quality-driven approach, with an unwavering dedication to maintaining the highest standards of quality.

This role offers a unique opportunity to make a significant impact on our company's commitment to quality and excellence. If you have a passion for quality control and a desire to contribute to a team that values precision, innovation, and collaboration, we encourage you to apply.

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