Quality Lead

Company Description

Gerresheimer is the global go-to partner for medicine packaging, drug delivery devices and solutions with the broadest product range for pharma, health, well-being and biotech. We bring every kind of medicine safely, reliably and conveniently to or into the patient. Customers and partners from all over the world approach us with new challenges. We are their solution provider with the absolute will to deliver, from the concept up to the final product. This is how we meet the needs of our customers and their customers – the users.

We are driven to achieve our ambitious goals through a high level of expertise, a focus on quality and the purpose of what we do. Thanks to the involvement of our comprehensive international network and their industrial competence, we know the markets and develop innovative and sustainable solutions.

We play an essential part in people's health and well-being and gladly accept the responsibility for this.

Job Description

The Quality Control Lead is responsible for maintaining an effective quality system and provide leadership to the employees in the quality department to ensure that all products manufactured by the facility meet customer specifications. This role must understand the balance between glass production and product quality. This role is a night shift that runs from 6pm - 6am on a 2-2-3 schedule.

ESSENTIAL DUTIES:

• Responsible for all product quality at the Chicago Heights plant. Must be able to identify glass defects on the line and make effective judgement calls to ensure no defective product is packaged for customer orders.
• Directs the activities of the Quality Inspectors, Q.C Lab personnel, and PDS Crewleader.
• Directs all resort activities for the Japanese Resort and oversees the Resort process including documentation, and Plant communication to Scheduling and Sales group.
• Takes full responsibility of communication with production departments to fix production issues.
• Supervises the Quality Department and Quality System of the Chicago Heights Plant.
• GMS and QMS site leader.
• Ensures compliance with the ISO-9000 standards.
• Works with internal staff to resolve quality issues.
• Assists Plant and Company Management in preparing quality related reporting and presentation materials. 
• Investigates customer complaints using root cause analysis tools and methodology.
• Qualify job changes
• Perform batch record review on daily quality control line paperwork
• File quality control line paperwork
• Give defect training to new hires and customers, in addition to an annual defect class for all production employees
• Participates in plant management staff meetings and quality initiatives
• Maintaining and controlling calibration records for all test and inspection equipment
• Performing tests and measurements using existing measurement equipment to ensure product meets specifications.
• Participating in teams to help make necessary improvements and changes to all process related issues
• in the production on the Hot End and Cold End.
• Applying good manufacturing practice and enforcing that it is followed.
• Support and developing site GMP, GDP, and 5S programs including leading team meetings and related activities
• Respond to customer requests via email or phone.
• Ensures that quality relevant trainings are completed upon implementation and affectivity of the SOP.
• Facilitates quality related problem solving and work out sessions to address issues not requiring the formal DMAIC approach. (Only if not formalized as CIP project / initiative)
• Conducts special data analysis projects as requested by management.
• Facilitates project completion by recognizing and addressing organizational barriers.
• Instructs and coaches managers, supervisors and team leaders to establish performance measurement systems and goals aligned with organizational objectives.
• Utilizes Infinity QS or establishes Statistical Process Control charts where applicable and trains process owners in their proper use.
• Works with process owners and IT resources to make data available to process owners and for process improvement teams.
• Provides technical and statistical expertise to teams to enhance the quality of services/products.
• Observes all safety rules and regulations and performs job in a safe manner.
• Maintains acceptable standards of housekeeping & wears proper personal protective equipment (PPE)
• Lead and develop corrective & preventive actions in regard to internal and external customer complaints.
• SAP including processing requisitions and budget maintenance.
• Communicate plant mould equipment needs with vendors; follow up with planning to ensure timely deliveries. 
• Ability to identify complex problems related to production, develop and evaluate options, and implement solutions by developing procedures and training.
• Ability to read/understand blueprints, sketches and quality specifications to tolerances of +/- .001.
• Perform other duties as assigned by the Quality Manager.

Qualifications

EDUCATION/EXPERIENCE:

• A four-year college degree, preferably in a technical field, is strongly desired. In lieu of a degree appropriate job experience can be considered.
• Previous experience dealing with customers inside and outside of the facility.
• 5 years of experience working in manufacturing quality.
• Must work weekends as required by a 2-2-3 shift pattern
• Speak and write English fluently.

QUALIFICATIONS & SKILLS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• GMP and GDP compliance experience is required. Pharmaceutical packaging experience is a plus.
• Good communication skills; verbal and written
• Good interpersonal skills and organizational skills.
• Sound mathematical and technical skills.
• Ability to communicate with all levels within the organization.
• Analytical and synthesis skills.
• Supervisory skills combined with the ability to delegate.
• Organizational skills and ability to multitask (work on several projects at once).
• Project Management Skills
• Problem solving and analytical skills
• Ability to think logically and methodically.
• Ability to influence decision making independently and proactively.
• Excellent computer skills (Microsoft Office Suite).

Preferred Certifications:

• Lean Six Sigma Black or Green Belt preferred
• CSSBB, CQE, CQA, CQM or other quality certification preferred
• Project Management Certificates (PMI, PMP) is preferred

Additional Information

BEHAVIORAL ATTRIBUTES:

• A strong individual contributor that exhibits the company values-Integrity, Responsibility, Excellence, Innovation & Teamwork
• Able to maintain confidentiality
• Self-starter-able to work with minimal supervision
• Able to handle pressure of time constraints in meeting Quality goals
• Detail oriented, strong organizational skills
• Dependable, punctual and attentive
• Competent and conscientious