Job Information
West Pharmaceutical Services Quality Specialist, Document Control in Scottsdale, Arizona
Requisition ID: 66604
Date: Sep 11, 2024
Location:
Scottsdale, Arizona, US
Department: Quality
Description:
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.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary:
In this role, the Quality Specialist, Document Control is accountable for providing document control services to support manufacturing activities within a multi-functional team environment for medical devices. The Quality Specialist, Document Control will provide analytical support related to document control activities within the Quality team and will work closely with the Quality and Operations teams to identify areas of improvement within the Quality Management System. The Quality Specialist, Document Control will handle projects and tasks in support of product manufacturing and will play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting company and regulatory requirements.
The Quality Specialist, Document Control 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
Manage and maintain traceable, accountable, password protected, documentation system in compliance with Corporate and site Quality requirements to handle the needs for WKIs, SOPs, ESOPs, validations, training, and other various documentation.
Managing DHF documents and control activities (Electronic soft tools version including hard copies).
Configuration management processes including aspects of document control, change control (ECO) maintenance, action items implementation and follow up.
Plan, schedule, assist, with change management processes, meetings agendas and minutes to support product development and ensure requirements and milestones are met.
Ensure there are periodic reviews of all documents to maintain consistency to customer requirements, enterprise and local procedures and changes or improvements to site processes.
Ensure consistency of document structure & compliance to company procedures, ISO standards & cGMPs.
Contribute to & support the development of product development QMS procedures & work instructions
Collaborate with teams on the development of product development DHF documents, specifically in regard to facilitating document control activities
Work cross-functionally with individuals and projects teams to ensure successful documentation release.
Provide quality document control oversight on documentation and reports
Support internal and external audits as required in the backroom
Perform Internal audits as assigned per the schedule
Review documents for accuracy & completeness, including data verification activities to cGMP requirements.
Support the Quality team including but not limited to Failure Investigations, CAPAs, NCR assessments, audit findings, deviations, and QMS procedural improvements
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
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:
Associate degree in technical or business-related field / Bachelor’s degree preferred
Minimum 3-5 years of experience in regulated Quality Assurance / Quality Control
Relevant work history and/or experience may be considered in lieu of degree.
Experience with managing Document Control activities within a regulated industry
Ability to work independently, multi-task and thrive in fast-paced environment
Excellent written and verbal communication skills
Must have effective problem solving and interpersonal skills
Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
Ability to accurately collect and organize data
Preferred Knowledge, Skills and Abilities:
Experience with quality systems such as ISO 13485, 21 CFR 820
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
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
Competencies/Authorities
- Non-US only where required for certain levels
#LI-KR1
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.
Quality Specialist, Document Control
West Pharmaceutical Services
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