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Form of workJob Description
Responsibilities:
Serves as an internal auditor and a member of the Quality Systems team. Serves as technical/subject matter specialist for compliance related issues and works to resolve these issues and improve quality. Assists in the day- to-day operations of Quality Systems processes, such as Document Control Management, Change Control Reviews, Quality Investigation and Root Cause Analysis, OTC batch record audits and Quality process training across the organization. Responsible for quality activities for the Finished Good Specifications, OTC Batch Record, OTC Finished Good Release, Annual Product Review, FDA Audit Readiness, Key Performance Indicators, and Quality Event Management.
Requirements:
3+ years of Quality Control experience
Bachelor's - Chemistry, Microbiology
Certified Quality Auditor, Certified Quality Engineer, or Certified Quality Manager - Preferred
Must have a good understanding of advanced quality principles, of audit protocol, inspection procedures and FDA and cGMP regulations. Must be familiar with compliance requirements for over the counter (OTC) products. A knowledge and understanding of multiple manufacturing processes/formulations, international requirements and bilingual skills are beneficial.
Ability to apply advanced principles, theories, and concepts and contribute to the development of new principles, systems and concepts.
Must be a critical thinker and active listener with good time management ability to provide solutions and define deliverables to a wide range of difficult and complex problems which require the regular use of ingenuity and creativity. Solutions should be imaginative, thorough, and practicable
Serves as an internal auditor and a member of the Quality Systems team. Serves as technical/subject matter specialist for compliance related issues and works to resolve these issues and improve quality. Assists in the day- to-day operations of Quality Systems processes, such as Document Control Management, Change Control Reviews, Quality Investigation and Root Cause Analysis, OTC batch record audits and Quality process training across the organization. Responsible for quality activities for the Finished Good Specifications, OTC Batch Record, OTC Finished Good Release, Annual Product Review, FDA Audit Readiness, Key Performance Indicators, and Quality Event Management.
Requirements:
3+ years of Quality Control experience
Bachelor's - Chemistry, Microbiology
Certified Quality Auditor, Certified Quality Engineer, or Certified Quality Manager - Preferred
Must have a good understanding of advanced quality principles, of audit protocol, inspection procedures and FDA and cGMP regulations. Must be familiar with compliance requirements for over the counter (OTC) products. A knowledge and understanding of multiple manufacturing processes/formulations, international requirements and bilingual skills are beneficial.
Ability to apply advanced principles, theories, and concepts and contribute to the development of new principles, systems and concepts.
Must be a critical thinker and active listener with good time management ability to provide solutions and define deliverables to a wide range of difficult and complex problems which require the regular use of ingenuity and creativity. Solutions should be imaginative, thorough, and practicable
