Job Details
At the heart of the Stevanato Group s vision is the desire to develop innovative solutions to solve complex problems for our customers across the pharmaceutical industry providing them products, processes and services that guarantee the integrity of parenteral drugs in a way that is far superior to anything that has been achieved before. With a worldwide presence, Stevanato Group employs more than 3,600 people who share this commitment towards customer satisfaction and patient well-being. Joining Stevanato Group you become part of a group of highly dedicated people who pursues its business goals driven by an ethical and transparent mindset, fostering innovation.
The Quality Line Reference Lead is responsible for overseeing shift safety, quality, and performance for all QLR technicians on their assigned shift. They also dually serve in the QLR technician role as needed to support business needs.
Essential functions:
Startup and sustained inspections
- Establish suitable training of QLR team within and across shifts to ensure consistent measuring, inspection, and documentation of results. Develop methods to periodically assess ongoing capability of team.
- Plan and schedule workload to ensure suitable and consistent coverage across all equipment lines and functional areas.
- Periodically monitor LIMS results to look for trends in data patterns, and use these results to both identify and support cross functional improvements.
- Partner with bulk technicians to evaluate any out of specification conditions to ensure documentation is accurate and timely and suitable follow up activities occur.
In-process sorting
- Schedule and track results of QLR team as it relates to in-process sorting activities.
Quality Audit/Inspection Support
- Participate in inspections/audits by providing applicable information to fulfill requests of inspectors/customers with potential interactions to explain relevant data, documentation, and rationale.
Requirements:
- Previous experience in a quality control environment as a quality lead.
- Strong attention to detail.
- Excellent communication skills to effectively communicate any issues or concerns.
- Knowledge of applicable regulatory standards such as ISO 9001, ISO 13485 and applicable FDA cGMPs.
- Knowledge of device manufacturing/pharma Quality Management System processes and features.
- Experience in healthcare device/pharma manufacturing environment.
- Ability to travel to Italy at corporate office for training.
- Ability to work 3rd shift (10 pm to 6:30 am)
- Ability to work weekends
Stevanato Group is an Equal Employment Opportunity (EEO)
employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.