Quality Auditor - Fixed Term Contract

West Pharmaceutical Services•Tempe, AZ

1d•Onsite

About The Position

The role is essential in ensuring in-process and finished products meet customer specifications. This role provides total manufacturing quality inspection services including quality inspection, quality control, sampling inspection, documentation and record keeping. Adhering to Good Documentation Process (GDP) is essential to maintain all documentation necessary to ensure conformity to specifications and traceability of records.

Requirements

High School Diploma or GED Required
1 year manufacturing experience required.
Basic computer skills.
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

Able to be aware of all relevant standard operating procedures as per Company policy.
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.