Title: Quality Associate

Requisition ID: 68583

Date: Mar 23, 2025

Location:

Cidra, Puerto Rico, US

Department: Quality

Description:

Shift: 12 Hour Shifts

Rotate 4 days on / 3 days off

Hours: 5:00PM - 5:00AM (but must be available for AM/PM shift)

Hourly Pay: $12.50/hour

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

Supports the management of the Quality Department by assisting in evaluating product quality, auditing implemented systems, conducting process and documentation audits, and reporting non-conformity events. Ensures that required documentation complies with Good Manufacturing Practices (GMP), ISO 13485, Good Documentation Practices (GDP), and customer specifications.

Accountabilities

• Ensures that only approved materials are ready for storage or production. Determines product status and releases them for use. Notifies the Quality Supervisor or prepares non-conformity reports when necessary.

• Interprets drawings, blueprints, specifications, and procedures for various product tests or measurements. Uses testing and measuring equipment in Quality and Manufacturing areas and applies Statistical Process Control (SPC) techniques for quality system prevention when necessary.

• Audits and approves manufacturing processes and reviews manufacturing records to authorize the release of final products.

• Ensures that required documentation complies with GMP, ISO, GDP, and Tech Group Quality Standards.

• Supports and ensures compliance with ISO, GMP, GDP, and FDA standards. Conducts periodic audits during manufacturing processes.

• Follows established health and safety regulations to prevent accidents.

• Actively supports the organization’s Lean Manufacturing and Six Sigma initiatives.

Education

Associate Degree or equivalent.

Work Experience

• 3-5 years of experience in Manufacturing Process Inspection and Auditing, preferably in injection molding.

• Experience using calipers, weight scales, and optical comparators.

• Basic math skills.

• Knowledge of SPC (Statistical Process Control).

• Knowledge of GMP, GDP, and ISO standards, preferably ISO 13485:2003.

#LI-CC1 #LI-ON-SITE

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. 