Quality Auditor - Fixed Term Contract

West Pharmaceutical Services•Tempe, AZ

3d•Onsite

About The Position

The Quality Auditor provides manufacturing quality inspection services to ensure in-process and finished products meet customer specifications. The role involves quality inspection and control, sampling, documentation, and record keeping, with adherence to Good Documentation Process (GDP) to ensure product conformity and record traceability. This is an onsite, fixed-term contract projected to last nine months, with full-time hours and benefits. The scheduled shift is Thursday, Friday, Saturday, and every other Wednesday from 5:45 PM to 6:00 AM. A $1,000 bonus is offered at 12 and 24 weeks for team members who complete those milestone dates. West describes itself as a company focused on improving patient lives through injectable medicines and highlights opportunities for learning, growth, and development, benefit programs supporting team members’ and families’ well-being, community giving, and sustainability efforts.

Requirements

High school diploma or GED.
Ability to be aware of relevant standard operating procedures in accordance with company policy.
Ability to work independently and as part of a team, with self-motivation, adaptability, and a positive attitude.
Ability to learn and review analytical techniques.
Ability to meet individual and departmental goals.
Ability to learn, understand, and remember normal tasks.
Ability to hear, speak, and understand conversation in English.
Ability to work well with others in a variety of situations.
Ability to multitask, work under time constraints, solve problems, and prioritize.
Ability to read and interpret data, information, and documents.
Ability to work under deadlines with constant interruptions.
Medium exertion: occasionally exert up to 50 lb/22 kg of force, frequently up to 20 lb/9 kg, and constantly up to 10 lb/4 kg to move objects.

Nice To Haves

One year of manufacturing experience preferred.

Responsibilities

Perform sampling, inspections, and testing of in-process and finished goods according to applicable procedures and AQL plans, using visual inspection and calibrated test equipment.
Release acceptable in-process and finished goods for further processing or shipping.
Understand and follow applicable ISO standards requirements.
Review inspection records to verify product conformity and proper documentation practices.
Retain finished-product samples, maintain applicable documents for batch records, and ensure appropriate batch-record disposition, such as filing or scanning.
Print documents from Master Control, shopfloor, or other software and manage documents related to the Quality System.
Segregate nonconforming product and handle quarantined product and raw materials as applicable by site.
Generate rejection and deviation reports as directed by the site.
Perform trace-back investigations of nonconforming raw material and product as directed by the site.
Promote and support a Lean environment and contribute to Lean Sigma programs and activities toward established targets.
Comply with corporate and site-specific regulations, policies, work procedures, instructions, and safety rules.
Maintain regular, reliable, punctual, and predictable attendance.
Provide customer service when interacting with internal and external customers while completing work and meeting production and quality standards.
Maintain a clean, orderly, and safe workstation and environment.
Keep current with new GMP compliance guidance and internal QA procedures, and support new GMP compliance guidance and Data Integrity initiatives.
Perform other duties as assigned based on business needs.