Specialist II, Quality Systems

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.

Job 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

Minimum 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)

Preferred Requirements

• 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.

Other Ideal Personal Characteristics

• 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

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.