Title: Quality Auditor

Requisition ID: 62677

Date: Sep 12, 2023

Location:

Scottsdale, Arizona, US

Department: Quality

Description:

This position is for Thursday - Saturday with every other Wednesday 5:00 AM - 5:15 PM.

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.

POSITION SUMMARY:
The Quality Auditor role is essential in ensuring in-process and finished products meet customer specifications. Quality Auditors provide 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Perform in-process dimensional and visual audits to ensure compliance to all customer cosmetic and dimensional specifications.
Operate and maintain all dimensional inspection equipment.
Document, record and file inspection results.
Communicate inspection results to applicable personnel.
Perform start-up and restart verification of part performance to specifications of all molding machines and secondary operations.
Assist shift employees with quality issues and/or measurement techniques.
Take record of environmental monitoring devices.
Performs monthly particulate count.
Determine whether a Non-Conformance (NCR) has occurred and follow established procedures to initiate corrective actions.
Assist with Change Requests (DCN/ECR) to improve or clarify established procedures.
Assist in the inspection of incoming materials.
Verify the Device Master Record (DMR) and enter data into the applicable computer systems.
Contribute to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
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.

REQUIRED QUALIFICATIONS:

Education or Equivalent Experience: High School or equivalent
Experience: 0-3 years of experience

PREFERRED QUALIFICATIONS:

Vocational, technical training or degree with emphasis in Quality Control
Experience working in manufacturing environment
Experience working in medical device or other regulated industry

PHYSICAL & MENTAL REQUIREMENTS:

Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources.
Maintain company and customer confidentiality at all times.
Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments.
May stand or sit for extended periods of time.
Use hands/fingers to handle or feel or operate objects, tools or controls and reach with hands and arms.
Must transport oneself to and from other areas of the facility and travel to other divisions when necessary.
Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
Must be able to 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.
Learn and apply new information or new skills
Must be able to understand direction and adhere to established procedures.
Must be able to effectively communicate in/understand the English language in verbal and written form.
Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
May be required to lift heavy objects up to 25lbs without assistance.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.