Title:  Quality Specialist, Document Control

Who We Are:

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 $2.14B in 2020. 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, 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’s 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 PowerPoint.
• 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:

• Must be able to travel up to 5% of the time.

Physical and 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.

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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 Apply.Accommodation@westpharma.com.  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.