Job Description
Do you believe in quality, service and team spirit? Then implement these values together with us.
Make a difference as a
Quality Control Manager
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2020 sales of $2.14 billion reflect the daily use of approximately 112 million of its components and devices which are designed to improve the delivery of healthcare to patients around the world.
Location: Stolberg, North Rhine-Westphalia, DE
Department: Quality
Job summary
In this role, you will monitor and control the daily activities of quality inspections of incoming, in-process, final, and batch record review and release. In his position, you will manage the Quality Control team to ensure the inspection process is executed in a proper and timely manner by ensuring procedures are followed and improved as part of a continuous improvement mindset.
- Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary.
- Directly reports to include quality control supervisors.
- Leads and directs the incoming inspection, in-process inspection, and batch release teams with a positive and patient attitude.
- Maintains and instills in others a “quality at the source” mentality as it pertains to all aspects of manufacturing, including documentation, training, and other functions related to production.
- Maintains and instills in others an “immediate audit readiness” mentality so that records and actions are executed in a way that ensures their accuracy, legibility, and immediate retrievability.
- Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
- Schedules and prioritizes quality inspection, testing, and batch record review and release to supports operations and product release.
- Identifies and develops opportunities to improve existing processes and procedures.
- Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer's experience.
- Works with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
- Manages the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow-up activities are accomplished.
- Reviews documentation and records for accuracy. Determines if the product is impacted, can be released, or if non-conformance report is required.
- Manages the development of documentation and procedures during the qualification of new equipment/inspection methods.
- Exhibits regular, reliable, punctual and predictable attendance.
- Creates, prepares, implements and improves quality control KPI metrics.
- Determines / sets goals and objectives for the quality control organization and training programs for team's development purposes.
- Supports investigations related to non conformances, audit observations, CAPAs, or Issue reviews as needed.
- Ensures equipment is up to date on preventive maintenance and calibration activities.
- Maintains the QC area well organized with a 5S mindset.
- Other duties as assigned
- Participate in special project teams as assigned.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
- Exhibits regular, reliable, punctual and predictable attendance.
- Associate's degree in a technical or engineering subject required or
- Bachelor's degree in technical or engineering preferred
- Minimum 8 years previous experience in quality control required and
- Experience in an FDA-regulated environment pertinent to ISO 15378 preferred
- Must be familiar and proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Master-Control, SAP
- Able to comply with the company's safety policy at all times
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target
- Metrology equipment experience
- Leadership experience in leading teams preferred
- 5%: Up to 13 business days per year
Sedentary-Exerting up to 10 lbs / 4 kgs of force occasionally and / or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
- This job requires decision-making based on data analysis
- Must be able to generate, express, and exchange new ideas
- Must be able to understand direction and adhere to established procedures
- Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
- Organizational skills will enable planning, prioritization & achievement of goals, especially of importance for the successful execution of related activities
- Read and interpret data, information and documents
- Must maintain the ability to work well with others in a variety of situations
- Must be able to multi-task, work under time constraints, problem solve, and prioritize
- Ability to make independent and sound judgments
- Observe and interpret situations, analyze and solve problems
- Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events
- Internationality – As an American company, we live a global cooperation within international structures
- Philanthropy – We value an appreciative and friendly work environment as well as flat hierarchies
- Market-appropriate remuneration – We offer an attractive, market-oriented remuneration, including company social benefits and purchasing benefits
- Social engagement – We support local aid organizations through various actions organized by our employees
- Diversity – We at West value the wide range of our employees who make up our company
- Safety – Occupational safety is our highest priority; we offer secure jobs in a sustainable industry
- Development opportunities – Our employees benefit from an extensive range of trainings as well as from a constant and targeted employee development
- Family-friendly culture – We attach great importance to reconciling private life and work; flexible working hours are a matter of course for us