Quality Auditor - Fixed Term Contract

West Pharmaceutical Services•Tempe, AZ

1d•Onsite

About The Position

In this role you will be responsible to independently provide analytical review of the data generated for internal and external customers as well as supporting post-production related Quality activities such as finished batch release, including sterilization, packaging specifics, work order approval and support additional quality department activities. This position also requires maintaining knowledge of the current local and/or International regulations/guidelines/policies applicable to West's products and services.

Requirements

High School Diploma or GED Required.
Min required 1 years of experience required
Able to be aware of all relevant standard operating procedures as per Company policy
Ability to learn, understand, and remember normal tasks.
Ability to hear, speak, and understand conversation in English.
Must maintain the ability to work well with others in a variety of situations.
Must be able to multi-task, work under time constraints, problem solve, and prioritize.
Read and interpret data, information and documents.
Work under deadlines with constant interruptions.

Nice To Haves

Support and contribute to Lean Sigma programs and activities towards delivery of the set target
Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
Willingness to learn new and review new analytical techniques
Meet individual and departmental goals as required

Responsibilities

Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans, utilizing both visual means as well as calibrated test equipment to include laser micrometer, optical comparator and other equipment as applicable
Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site
Understand and follow applicable ISO standards requirements
Perform review of inspection records to assure product conforms to specifications and proper documentation practices
Retains sample of finished products and maintains all applicable documents to form batch records and ensures appropriate batch records disposition (i.e. filing, scanning etc.) as necessary
Print documents from Master Control, shopfloor or other software program and manages 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 site
Perform trace back investigation of nonconforming raw material and product as directed by site
Promotes and supports a Lean environment.
Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules
Exhibits regular, reliable, punctual and predictable attendance.
Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
Maintain a clean, orderly, and safe workstation and environment at all times.
Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
Exhibit regular, reliable, and punctual attendance.
Perform other duties as assigned based on business needs.
Keep current with new GMP compliance guidance and internal QA procedures
Support new GMP compliance guidance and Data Integrity initiatives