West Pharma Quality Associate 

United States, Puerto Rico 

220665871

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.

• 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.

Associate Degree or equivalent.

• 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.