The Quality Engineer (QE), under limited supervision, facilitates operational process improvement through metrics, problem identification, root cause analysis and developing and implementing corrective action.
The basic purpose of the QC Reviewer is to assure the quality of laboratory data and reports. This is accomplished by reviewing chromatographic data and related notebooks as specified by Standard Operating Procedures.
In this role, you will monitor and controls quality specifications by establishing and monitoring protocols and documentation requirements. The QE must be able to coordinate customer, supplier, and internal manufacturing issues.
The Quality Engineer role is responsible as the key liaison between manufacturing and the customer, ensuring that overall customer quality and regulatory requirements and expectations are met and product meets all specifications.
In this role, the selected candidate will perform regular supplier audits to ensure compliance with regulatory standards, as well as participating in strategic development based on quality control plans.
The Principal Software Developer takes a leading role in software development and will be responsible for architecture, design and development of real-time analytics and machine learning product line of My:Time Digital Platform. The successful candidate has a solid working knowledge of commonly used development concepts, practices and procedures.
The primary purpose of this position is to provide analytical support to the production and formulation departments. This company is located in the Madison, WI area which is a great place for both single people and people with families.
Work with the DCHU and Support teams to ensure the compliance of the complaint handling program to ensure complaints are identified, processed, and investigated per internal procedures and regulatory requirements.
Provide insight and individual contribution in obtaining and maintaining compliance with ICH Q7 guidance for active pharmaceutical ingredients. Troubleshoot method and process issues in assurance of successful validation. Recommend technical design/changes to improve efficiency, quality or performance in support of validation.