At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
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Job Summary
Reporting to the Design & Quality Assurance Director, the job holder will be the QA lead supporting West proprietary design & development projects (in Elastomer & Primary Containment) with key focus and responsibility around the interpretation, application of and compliance to relevant standards, regulations and internal procedures. The Senior Quality Engineering Specialist will manage the quality aspects of West proprietary design & development projects; will provide West proprietary design & development teams with guidance on design quality-related issues and design control best practices; and drive a culture of compliance and continuous improvement within West proprietary design & development teams.
Essential Duties and Responsibilities
- Program Activities:
- Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; regulatory requirements; international standards; and enterprise and local procedures.
- Identify and support the use of improved quality practices by R&D teams during design control activities; and facilitate the smooth integration of quality requirements into design processes.
- Report on the progress of projects; identify successes; and drive compliance.
- Escalate quality-related issues to the Design & Quality Assurance Director or designee, as required.
- Review and approve relevant design history file documents; product drawings; component specifications; labelling; procedures.
- Support design transfer activities for commercial and launch readiness and sustainment.
- Verification and Validation Activities:
- Review and approve test method validations (protocols and reports).
- Review and approve design verification and design / process validation documents (e.g. protocols & technical reports).
- Facilitate and support the completion of projects up to and including PQ.
- Risk Management Activities:
- Responsible for authoring and/or reviewing and approving Risk Management Plans, risk assessments and Risk Management Summary Reports for proprietary design & development projects.
- Facilitate and/or participate in risk assessment meetings with proprietary design & development teams.
- QMS Activities:
- Support enterprise procedures updates that impact design and development activities.
- Drive the closure of change controls and protocol non-conformance reports (PNRs).
- Review and draft relevant procedures and forms for the management of activities connected with product design & development.
- Act as the interface between development teams and operational quality:
- Perform first article component and product inspections
- Draft defect libraries and quality inspection documents during OQ; and manage formal hand over of same to Operational Quality prior to PQ.
- Support the supplier selection process in accordance with West supplier management procedures.
- Conduct and support internal and supplier audits, as required.
- Lead internal audits of R&D and support site QA in the preparation and hosting of third party and customer audits.
- Lead and manage QMS activities including CAPAs, Failure Investigations, Non-Conformance assessments, audit findings, issue reviews, document control, change controls, and configuration management. Provide direction on non-conformances, deviations, or excursions and drive to closure.
- Actively engage in robust problem-solving to address quality issues.
- Metrology Activities:
- Review and approve metrology data during OQ & PQ.
- Support Quality Function Deployment activities (QFD).
- Compliance to all enterprise and local company policies and procedures.
- Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
- Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
- Perform additional duties at the request of the direct supervisor.
Education
- Bachelor'sDegree in Chemistry, Engineering or Quality discipline required
Work Experience
5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors.
Desirable: Regulatory Affairs experience
Preferred Knowledge, Skills and Abilities
- Must have practical experience working with design teams and providing design assurance support according to international regulatory requirements.
- Working knowledge of ISO 13485, ISO 9001, ISO 15378 and 21 CFR Part 820 is essential
- Work experience in the life science industry or another highly regulated, international environment would be considered an advantage
- Experience in Project Management
- Experience in process technology, by preference with elastomers.
- Risk Management experience within design and development with good working knowledge of ISO 14971.
- An excellent understanding of rubber and plastic manufacturing technologies, analytical methods and testing.
- Knowledge of analytical tools and methods, including statistics (Minitab preferred).
- Must be able to organise and prioritise tasks.
- Must have critical reading skills, maintain a high attention to detail and overall quality of work.
- Must be self-motivated, able to prioritize and multi-task, work independently and make sound judgements, work under time constraints, thrive in face-paced environments.
- Strong problem-solving skills, including root cause failure analysis methods.
- Must have excellent written and verbal communication skills.
License and Certifications
- ISO 13485/9001/15378 Auditor or Lead Auditor Training / Certification upon hire is preferred.
Additional Requirements
- Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
- Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
- Ability to work independently, multi-task and thrive in fast-paced environment.
- Strong problem-solving skills including root cause failure analysis methods.
- Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
- Must maintain the ability to work well with others in a variety of situations.
- Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
- 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. #LI-JJ1
Travel Requirements
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [email protected]. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.
