Quality Technician

Description
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.
Please note this role is a FTC shift role working hours 8pm - 8am & 8am - 8pm on rotation
Job Summary
In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained. Reporting directly to the Senior Quality Engineer.

Essential Duties And Responsibilities

Review and approval of metrology reports, where appropriate, for batch release and validation purposes

New product validation, analysis and reporting.

Quality support to Engineering and Production Departments.

Establish and maintain documentation in line with West Dublin and West Pharmaceutical Services Quality Systems.

Liaise with customers and suppliers on new and existing projects.

Receiving and inspection of incoming goods and materials

Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications.

Maintain good communications both internally and externally.

Ensures that all metrology equipment is correctly calibrated.

Assists shift personnel with quality issues and/or measurement techniques.

Assists in problem resolution with customers.

Makes periodic audits as requested and completes necessary documentation.

Archives quality records, samples and log procedures.

Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.

Batch paperwork review and final decision to release product for shipment

Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.

Compliance to all site Environmental, Health and Safety requirements, training and regulations.

Compliance to all local site company policies, procedures and corporate policies.

Perform additional duties at the request of the direct supervisor.

Other duties as assigned.

Basic Qualifications

Must possess good communication/interpersonal skills; must be detail oriented, organized, flexible and be able to handle multiple tasks and time critical projects/deadlines.

Must understand the principles of Batch Control and FIFO.

Must be able to hold a high degree of confidentiality.

Must have knowledge of EU-GMP

Computer literacy required.

Preferred Knowledge, Skills And Abilities

Ideally have a third level qualification in Quality/Mechanical/Plastic Engineering and/or have relevant industrial experience in a high volume injection-moulding environment.

Basic knowledge of statistical sampling of product

Understanding of injection moulding processes.

Working knowledge of ISO 9001/ ISO 13485 and FDA Code of Regulations CFR part 820 preferred.

Travel Requirements

N/A

Requirements
Physical and Mental Requirements:

Physical Requirements: must be able to be exerting up to 10lbs / 4kg of force occasionally, and / or negligible amount of force frequently or constantly to life, carry, push, pull or otherwise move objects.

Mental Requirements: must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data.

Delegation Of Duties
When absent from the site duties and responsibilities will be delegated to the following designates

Quality Engineer

Senior Quality Engineer

Quality Engineering Manager

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.

Seniority level

Entry level

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing

Packaging and Containers Manufacturing

Pharmaceutical Manufacturing

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