Manufacturing Line Quality Engineers operate as independent Quality resources, partnering with Production to ensure compliance with GMP, GDP, and quality standards. They are responsible for assisting in the implementation and maintenance of an effective Quality System for the site.
Responsibilities
Perform line clearance, shift change activities, set up verification, and label verification.
Contribute independently to Quality System processes, including training, corrective and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, and validation.
Coach and reinforce quality attributes and requirements, providing technical assistance as needed.
Utilize quality management techniques to perform investigations and facilitate solutions independently.
Complete documentation in a timely manner and in accordance with business standards.
Maintain the effectiveness of the Quality System.
Understand and comply with applicable EHS policies, procedures, and guidelines.
Qualifications
0-2 years of experience.
Demonstrated technical competency and working technical knowledge.
Ability or aptitude to work on problems of moderate scope.
Ability to form and develop interpersonal, and professional relationships.
Ability to work independently and in groups, cross-functionally.
Ability or aptitude to exercise judgment within defined procedures and practices.
Demonstrated initiative, problem-solving, and critical-thinking skills.
Ability and aptitude to use various types of databases and computer software.
Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.