Quality Assurance Specialist

Quality Assurance Specialist

This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity.

Who We Are :

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 we are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

In this role the Quality Specialist, Compliance is responsible for maintaining the ongoing compliance of the Quality Management System. Quality Specialist, Compliance is responsible for the administration of the Document Management system on site including coordination of all document change request activities for their nominated area of responsibility. The Quality Specialist, Compliance will provide training and analytical support in the operation of the relevant GMP systems (MasterControl, SAP etc.). The Quality Specialist, Compliance is responsible for supporting the onboarding of new hires including participation in the Induction Program and Annual GMP Training. The role is also responsible for performing data analysis and reporting of Quality System Metrics internally and globally. The Quality Specialist, Compliance will play an active role in ongoing Quality projects as required.

Essential Duties and Responsibilities

• Function as Sub Administrator for the site Quality Event Management System to manage and maintain traceable, accountable Quality Records in compliance with Corporate Guidelines
• Provide Quality document control oversight on documentation and reports.
• Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations, and standards.
• Responsible for management of Systems Training developing, scheduling, and performing.
• Responsible for management of Document Management Training on site developing, scheduling, and performing.
• Responsible for management of GMP Training including Induction and Annual developing and performing.
• Support generation of data for Management Review.
• Management of Site Metrics generation (weekly and monthly) including reporting out Globally.
• Responsible for ensuring compliance to GMP review requirements to maintain compliance to customer requirements and enterprise procedures.
• Work cross functionally with individuals and project teams to ensure successful documentation release.
• Acting as compliance representative on Quality Projects within the site.
• Participation in Internal Audit Program.
• Support in the preparation and hosting of Third-Party Audits including audit training and control room set up.
• QMS compliance tracking and trending of issues and patterns to drive improvements.
• Interface with other West sites with respect to sharing of best practices.
• 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.
• Other duties as assigned.

Basic Qualifications

Preferred Knowledge, Skills and Abilities

21 CFR Part 820 and / or Knowledge of 21 CFR Part 210 / 211 would be considered an advantage.

Auditing experience to CFR 21 Part 820, and / or CFR 21 Part 11 is considered an advantage.

Travel Requirements

5% : Up to 13 business days per year.

Physical Requirements

Sedentary-Exerting up to 10lbs / 4kgs of force occasionally, and / or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

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.