Specialist II, Quality Systems

Resilience • East Norriton Township, PA

8d • $65,000 - $87,500

About The Position

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Position Summary & Role This role is accountable for developing and maintaining a compliant, well-organized, and effective GMP quality management program at a highly digital manufacturing plant. The responsibilities for this role will cover all aspects of a GMP Quality Systems, including training, document management, deviations, CAPAs, and change controls. The Quality Systems Specialist is a key quality function and reports to the Quality System Lead. The position will be located in East Norriton, PA.

Requirements

• Demonstrated quality experience and the ability to collaborate with and effectively influence others.
• Knowledgeable with quality systems/software applications.
• Working knowledge of GxP Regulatory requirements.
• Proficient with Microsoft 365 products (Word, Excel, PowerPoint, Outlook)

Nice To Haves

• B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).
• 2-5 years relevant life sciences quality experience within quality and/or quality related functions.
• Minimum of 2 years of QA systems experience.
• Hands-on experience with the management of Quality records (e.g. deviations, change controls, CAPAs, etc).
• Experience with Computer Systems Validation.
• Experience in preparation and participation in client audits or regulatory authority plant/site inspections.
• Performs with integrity.
• Excellent oral and written communication skills.
• Comfortable in a fast-paced, collaborative company environment and able to adjust workload based upon changing priorities.
• Reputation for superior customer service.
• Driven to reduce complexity and create simple and organized data systems.
• Proficiency in creating high quality procedures that are easy to read and understood.
• Desire and interest to leverage new technology and innovative information management tools

Responsibilities

• Administer, maintain, and improve core quality systems such as Document Management System, Learning Management Systems, and Quality Management Systems
• Review, route, and manage controlled documents, SOPs, Forms, throughout their lifecycle
• Assist with document disposition activities and act as site Business Process Owner (BPO), as needed.
• Author and review technical documents including but not limited to SOPs, various quality reports.
• Support internal audits, client audits, and regulatory inspections
• Support additional Quality initiatives both inner and interdepartmentally, as needed
• Support onboarding of new employees across the site
• Assist with training activities and act as site Business Process Owner (BPO), as needed.
• Manage and execute quality system processes including procedures, validation, deviation management, change control, CAPAs, etc.
• Maintain and organize the controlled document archive, ensuring timely filing, version control, and secure retention in compliance with cGMP, regulatory, and internal quality system requirements

Benefits

• Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees