Leads and assists in Quality Assurance related projects and day-to-day quality activities as needed
Represents the highest level of GMP understanding and accomplishment.
Supports the Quality Assurance Department in the following functions/projects.
Responsible for improving the efficiency and effectiveness of all engineering related quality systems.
Will have responsibility for generating or reviewing and approving the following document types: Equipment Qualification documents, Temperature Mapping, Water System Utilities, Environmental Monitoring, Risk Assessments, Cleaning, Write protocols and reports, Annual Product Reviews
Provide guidance and leadership where appropriate.
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace.

Four-year college or university program certificate in Chemical Engineering, Chemistry, Biochemistry, or related scientific field
6 years’ experience in Pharmaceutical Development and/or Manufacturing Operations
Ability to read, analyze, and interpret common scientific and technical journals, regulatory and compliance documents
Ability to effectively present information to management and colleagues
Competence in scientific mathematical skills and statistics, including metric analysis, trending, and reporting
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.

QA Engineer

Key skills