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Quality Control Analyst
2 months ago
Yoh, A Day & Zimmermann Company is looking for a Quality Assurance Investigator to join our team in the personal care sector. This role involves conducting Out of Specification (OOS) investigations in both microbiology and chemistry laboratories. A strong foundation in root cause analysis is essential.
POSITION OVERVIEW:
The Quality Assurance Investigator plays a critical role in leading and providing technical knowledge necessary for thorough investigations during laboratory OOS occurrences. This position leverages expertise in chemistry, microbiology, current Good Manufacturing Practices (cGMP), and analytical methodologies to facilitate the investigation process and produce comprehensive reports. The Quality Assurance Investigator collaborates with cross-functional teams to formulate appropriate corrective and preventive measures for confirmed OOS incidents.
Qualifications:
Education: A Bachelor's degree in biology, chemistry, or a related discipline is required. Relevant work experience may be accepted in lieu of a science degree.
Experience: A minimum of 3 years in a Quality Control/Quality Assurance role within an over-the-counter (OTC) drug, cosmetic, medical device, or food manufacturing environment is necessary. Laboratory experience is preferred. Familiarity with OOS investigations is required, along with experience in root cause analysis. Knowledge of the FD&C Act and 21 CFR Parts 210/211 & 11, as well as industry standards for pharmaceuticals and OTC products, is essential. Excellent communication and leadership abilities are mandatory.
Technical Competencies: Proficiency in project management, technical writing, data analysis, and an understanding of chemistry and microbiology laboratory testing and practices are crucial. Familiarity with analytical testing techniques and current Good Manufacturing Practices is also required.
Estimated Salary Range: $25.00 - $30.00
