Sr. Quality Engineer

West Pharmaceutical Services•Cidra, PR

2d•Onsite

About The Position

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 SummaryThis role is a fully onsite position and the Sr Assoc, Quality Assurance oversees projects, maintains processes and addresses quality issues by analyzing outcomes and collaborating with teams for effective resolutions. This position will continue the QA routine activities of a working WSS lab and QA duties for future business.

Requirements

Bachelor's Degree In Engineering or Science required
Minimum 5 years Experience in regulated Quality Assurance / Document/Configuration Control (or a formal education equivalent) required
Experience Leading Internal / External Audits, MasterControl, SAP and Share Point preferred
Ability to work independently, multi-task and thrive in fast-paced environment.
Excellent written and verbal communication skills
Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485.
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.

Nice To Haves

Master's Degree In Engineering or Science preferred
Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities preferred
Experience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820 preferred
Experience with customer interface and meeting customer expectations preferred
Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
Familiarity with root cause analysis tools
Working knowledge of MasterControl and SAP
Support and contribute in Lean Sigma programs and activities towards delivery of the set target
Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members

Responsibilities

Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes.
Create processes to better evaluate, track and trend audit outputs and identify risks/issues and evaluate impact on global quality systems and initiate actions, as needed.
Independently performs supplier audits and corporate facility audits.
Manage multiple project tasks and effectively coordinate handling of customer feedback and complaints.
Lead assessment and closure of customer complaints, ensuring adherence to established procedures and documentation.
Lead the evaluation and resolution of customer complaints, ensuring adherence to prescribed procedures and comprehensive documentation.
Coordinate communication between internal teams and customers
Regularly analyze data trends, drive improvements and meet customer expectations through efficient reporting and communication
Reviews, revises, and creates operating procedures to ensure compliance with all related external requirements, internal procedures or instructions, and the West Quality Manual.
Ability to lead meetings with customers, employees and contractors as necessary to manage changes.
Establishes monthly KPI’s and metrics to Quality Leadership.
Drive continuous quality improvement projects across the enterprise for increased compliance and to create efficient use of company resources.
Review and approve laboratory procedures, work instructions, ESOPs, EWIs, PFNBs, protocols, forms, method transfers, reports, analyst analytical training, etc.
Review all WSS documentation for compliance to West and/or Client policies and procedures, cGMPs and applicable ISO standards.
Liaise and collaborate with the WSS departments/clients to initiate, investigate, review and approve OOS investigations and reports and any other lab investigations as deemed necessary.
Conduct root cause analysis and issue appropriate corrective action when deemed necessary.
Work/interface with Lab personnel for continuous improvements related to CAPA and/or customer or regulatory requirements.
Plan, host and co-ordinate Customer, ISO, Corporate QA, and Regulatory audits/inspections of WSS facilities.
Coordinate the responses to customer audit observations, customer complaints and request for information/documentation.
Assure execution of internal quality audits, according to established procedures for the assigned areas / locations.
Provide response to audit observations, and customer complaints and inquiries.