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Quality Specialist

Job in Scottsdale - Maricopa County - AZ Arizona - USA , 85250
Company: West Pharmaceutical Services
Contract position
Listed on 2021-02-25
Job specializations:
  • Quality Control
  • Pharmaceutical
Job Description & How to Apply Below
Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate - which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients' lives each and every day - our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $1.84B in 2019. We serve by the side of our community. Giving back is in our DNA-our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

In this role, the Quality Specialist is accountable for supporting research and new product development activities within a multi-functional team environment for medical devices. The Quality Specialist will provide analytical support within the Quality team and will work closely with the research and engineering teams to identify areas of improvement within the Quality Management System. The Quality Specialist will handle projects and tasks in support of product development and will play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and other regulatory requirements.

The Quality Specialist will also execute transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other relevant quality functions as applicable including site audit support.

Essential Duties and Responsibilities:

* Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
* Collaborate with teams on the development of product development DHF documents, specifically in regards to facilitating document control activities
* Work collaboratively with internal customers to refine and optimize analysis and reporting criteria as well as manage expectations around analysis delivery timelines and output capabilities
* Work closely with research and development engineering teams
* Partner with and support the New Product Development Quality team in product development activities including but not limited to Failure Investigations, CAPAs, Non-Conformance assessments, audit findings, deviations, and QMS procedural improvements
* Develop and maintain quality related metric dashboards including but not limited to training, CAPAs, NCMRs, audit findings, issue reviews, and others
* Support the development of product development QMS procedures and work instructions
* Work cross-functionally with individuals and project or extended teams to ensure success of projects
* Drive solutions to ensure internal customer related problems/issues are communicated
* Establish routine communication strategies for project tracking and prioritization
* Drive continuous quality improvement projects
* Assure escalation of quality related issues to ensure effective remediation
* Attend program meetings as required as part of extended program teams
* Liaison with company and customers on Quality matters
* Other duties as assigned

Basic Qualifications:

* Bachelor Degree in Engineering or Science required
* Minimum 3-5 years of experience in regulated Quality Assurance / Quality Control
* Experience with Document Control
* Excellent written and verbal communication skills
* Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point

Preferred Knowledge, Skills and Abilities:

* Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities
* Experience with quality systems such as ISO 13485, 21 CFR 820.30
* Experience with MasterControl, SAP, Share Point, Teamcenter
* Able to be aware of all relevant SOPs as per Company policy and Quality Manual
* Able to comply with the company's safety policy at all times
* Able to comply with the company's quality policy at all times.

Travel Requirements:

* Minimal

Physical & Mental Requirements:

* 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
* 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
* Maintain high attention to detail, accuracy, and overall quality of work.
* Effectively communicate and interface with various levels internally and with customers.
* Able to be aware of all relevant SOPs as per Company policy and Quality Manual

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 disability or special need that requires accommodation, please send an email to (Please contact us using the "Apply for this Job Posting" box below) 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.
Position Requirements
Less than 1 Year work experience
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