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 2016 sales of $1.5 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.
Plan, schedule, execute & communicate all items regarding quality issues, complaints, validations & other projects to QA Senior Supervisor and Program Manager, and/or other interested parties. Be a strong advocate for product, process, and system quality at all stages of product realization. Participate in steering committees which originate from both customer and manufacturing facilities. Support customer complaint data acquisition, root cause analysis, corrective action and complaint handling. Also perform all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Exhibit a strong “quality first” mentality, and ensure that product and process quality are held to the highest standard.
- Review and approve product / process deviations or rework documentation.
- Provide quality reports and review trending on assigned areas of responsibility.
- Work independently and with project teams to develop design control deliverables including quality plans, manufacturing & inspection documentation, test methods, and any other necessary quality records.
- Participate in the development and maintenance of product risk and hazard analysis in accordance with ISO 14971.
- Meet company and departmental goals in the continuous improvement of all products, services and processes.
- 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.
- Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
- Maintain information and statistics on our site’s quality performance on a monthly basis including the site’s Cost of Quality data.
- Fill in for the Quality Senior Supervisor as requested or required.
- Perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols.
- Complete auditor certification and perform internal ISO and quality systems audits in accordance with ISO standards including recommending ways to resolve any issues identified by the audits.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Exhibits regular, reliable, punctual and predictable attendance.
- Education or Equivalent Experience: Bachelor's in Science, Operations, or Business
- Experience: 5-8 years of experience
- Experience using Six Sigma & SPC tools and techniques
- Experience with ISO 9000 and ISO 13485 standards and GMPs
- Excellent written and oral communication skills
- Excellent critical reading and writing skills
- Problem solving including root cause failure analysis methods
- Planning/organizational skills
- Computer skills required especially MS office applications and statistical analysis systems
- General understanding of manufacturing and plant operations
- ASQ certification (CQE or CQA)
- Green or Black Belt certification
- Chemistry or Engineering Degree
- Graduate degree
PHYSICAL & TRAVEL REQUIREMENTS:
- Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
- Must be able to work a 40 hour work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary.