This job has expired

You will need to login before you can apply for a job.

Specialist II, Quality Systems

Employer
Resilience
Location
East Norriton, PA
Start date
Nov 11, 2022

View more

Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country
You need to sign in or create an account to save a job.

Job Details

General Company Description

Resilience (Resilience US, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.

For more information, visit www.resilience.com.

Position Summary & Role (general description of the role; e.g. expectations, key milestones, impact)

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, internal audits, deviations, CAPAs, and change controls. The Quality Systems Specialist is a key quality function and reports to the Director, Quality. The position will be located in East Norriton, PA.

Job Responsibilities (core responsibilities; include people management if applicable)

  • Work collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program.
  • Build strong relationships and collaborate closely with CMC/Operations/Development teams and other relevant groups to ensure the quality documentation system complies with all US and International regulatory expectations.
  • Manage the site electronic quality management processes in alignment with network standards.
  • Lead all Quality System Review Boards.
  • Assist in deployment of global electronic Quality Management System (QMS) at East Norriton.
  • Assist with the document disposition activities, as needed.
  • Author and review technical documents including but not limited to SOPs, various quality reports.
  • Manage and execute quality system processes including procedures, validation, deviation management, change control, CAPAs, etc.
  • Manage Training curricula’s.
  • Create new training as needed.
  • Lead all trainings associated with the Quality Systems.
  • Coordinate and lead internal audits at the site.
  • Generate and manage quality metrics required by Quality Management.

Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)

  • 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.
  • Demonstrated quality experience and the ability to collaborate with and effectively influence others.
  • Expertise with electronic quality systems/software applications.
  • Hands-on experience with the management of Quality records (e.g. deviations, change controls, CAPAs, etc).
  • Experience with Computer Systems Validation.
  • Working knowledge of GLP/GCP and GxP Regulatory requirements.
  • Experience in preparation and participation in client audits or regulatory authority plant/site inspections.

Other Ideal Personal Characteristics:

  • 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

#LI-GJ1

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Find Us
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert