Quality Control Lead/Coordinator

7 days ago

Fenton, Missouri, United States Mallinckrodt Full time
Job Summary

Mallinckrodt is seeking a highly skilled and experienced Quality Control Lead/Coordinator to join our team. As a key member of our laboratory operations, you will be responsible for managing laboratory activities, ensuring compliance with regulatory requirements, and providing technical support to our production teams.

Key Responsibilities
  • Manage Laboratory Operations: Oversee the day-to-day activities of the laboratory, ensuring that all tasks are completed efficiently and effectively.
  • Ensure Compliance: Verify that all laboratory activities are in compliance with regulatory requirements, including Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Provide Technical Support: Offer technical guidance and support to production teams, ensuring that they have the necessary resources and expertise to meet production demands.
  • Investigate and Resolve Issues: Conduct thorough investigations and root cause analyses to identify and resolve laboratory-related issues.
  • Develop and Implement Process Improvements: Identify opportunities for process improvements and implement changes to increase efficiency and effectiveness.
  • Collaborate with Cross-Functional Teams: Work closely with production, quality, and other cross-functional teams to ensure that laboratory activities are aligned with business objectives.
Requirements
  • Education: Bachelor's degree in a science-related field (chemistry, biology, etc.) or equivalent combination of education and experience.
  • Experience: Minimum 5 years of experience in a laboratory setting, with a strong background in quality control and regulatory compliance.
  • Skills: Excellent technical writing and communication skills, with the ability to effectively communicate complex technical information to both technical and non-technical audiences.
  • Knowledge: Strong knowledge of GMPs, GLPs, and other regulatory requirements, as well as laboratory operations and quality control principles.
Preferred Qualifications
  • Advanced Degree: Master's degree in a science-related field or equivalent combination of education and experience.
  • Industry Experience: Previous experience in the pharmaceutical or biotechnology industry, with a strong understanding of laboratory operations and quality control principles.
  • Technical Skills: Proficiency in laboratory software and equipment, including chromatography and other analytical instruments.
Working Conditions
  • Work Environment: 70% laboratory exposure to plant products, solvents, and reagents, with some hazardous or potent compounds.
  • Office Environment: 30% office environment.
  • Shift Work: Required to work 8-12 hour shifts, with the potential for night, weekend, and holiday work depending on the lab.

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