West Pharmaceutical Services · 1 week ago
Quality Assurance Specialist
US Puerto Rico Cidra
Full-time
Onsite
Mid Level
3+ years expWest Pharmaceutical Services is a company dedicated to improving patient lives through innovative healthcare solutions. In this fully onsite role, the Quality Assurance Specialist will support all quality systems and functions, drive continuous improvement, and ensure compliance with ISO standards and cGMPs while interfacing with customers during audits.
BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical
Responsibilities
Coordinates and supports customer, ISO and corporate quality audits
Leads and assists in investigation of OOSs, complaints and deviations as necessary to identify and find the root cause of product and related quality issues
Develops and implements audit plans, schedules and supports internal audits. Prepares customer correspondence and audit responses related to quality audits. Prepares and coordinates audit and compliance related CAPAs
Supports communication and responses for typical customer questions e.g. during audits, and educates relevant functions accordingly
Supports all affected functions in bringing their systems and processes into compliance with GMP and DI principles and in maintaining that state
Participates in creation of Enterprise and local procedures on relevant QA topics and support all affected functions in their implementation
Assists with process and equipment validations as needed
Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or comply with corporate or regulatory requirements
Supports Quality requirements, including: System issues and investigations, Assist in assessment and disposition of non-conforming product, Assist in investigations and reporting, Review specification and sampling plans to ensure compliance
Promotes and supports a Lean environment within the facility
Performs other duties as required and/or assigned
Qualification
Required
Bachelor's Degree or equivalent experience
Minimum 3 years Quality department, ideally in a manufacturing environment
Preferred
Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
Quality planning and communication skills
Support and contribute to Lean Sigma programs and activities towards delivery of the set target
Demonstrated problem solving and planning/organizing skills
Demonstrated proficiency in MS Office products (Project, Word, Outlook, Excel)
Able to communicate effectively with clear, concise, and organized information, both verbally and in writing
Able to always comply with the company's safety policy
Company
West Pharmaceutical Services
West Pharmaceutical Services is a manufacturer of technologically advanced containment and delivery systems for injectable medicines.
5001-10000 employees
H1B Sponsorship
West Pharmaceutical Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (24)
2023 (18)
2022 (26)
2021 (17)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Eric Green
Chairman, President, and CEO
Atul Patel
Vice President, Devices & Delivery Systems
Recent News
2026-01-20
Company data provided by crunchbase