As a Quality Engineer I, you will operate as an independent Quality resource, partnering with Production to ensure compliance with GMP, GDP, and quality standards. You will play a key role in supporting the implementation and maintenance of an effective Quality System for the site, contributing to the overall quality and efficiency of manufacturing operations.

Key Responsibilities:

• Line Clearance & Verification: Perform line clearance, shift change activities, set-up verification, and label verification to ensure manufacturing processes adhere to quality standards.
• Quality System Processes: Contribute independently to Quality System processes, which may include training, CAPA activities, equipment maintenance, product and process planning, quality audits, and validation.
• Coaching & Technical Support: Coach and reinforce quality attributes and requirements, and provide technical assistance as needed.
• Investigations & Solutions: Utilize quality management techniques to independently perform investigations and facilitate effective solutions to quality-related issues.
• Documentation: Complete all required documentation in a timely manner, ensuring accuracy and compliance with business standards.
• Quality System Maintenance: Maintain the effectiveness of the Quality System, ensuring ongoing compliance and improvement.
• Additional Duties: Perform other tasks and duties as assigned, ensuring adherence to EHS policies, procedures, and guidelines.
• Supervision & Mentorship: Work under general supervision, with more experienced staff reviewing your results for accuracy and sound judgment. You may assist in training personnel and mentor others as directed by management.

Qualifications:

• Education: Bachelor’s degree in a relevant field.
• Experience: Minimum of 2 years of relevant experience, demonstrating technical competency and working knowledge of quality engineering concepts, practices, and procedures.

Skills & Abilities:

• Ability to work independently and as part of a team.
• Strong interpersonal and professional relationship-building skills.
• Proficiency in problem-solving, critical thinking, and project management.
• Ability to prioritize tasks and manage multiple projects simultaneously.
• Aptitude for quickly learning new knowledge, skills, and technologies.
• Familiarity with various databases and computer software tools.