This job has expired

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

Senior QA Operations Specialist (Cell Therapy)

Employer
Resilience
Location
East Norriton, PA
Start date
Aug 9, 2022

View more

Discipline
Clinical, Clinical Medicine, Science/R&D, Biotherapeutics
Required Education
Associate Degree
Position Type
Full time
Hotbed
Pharm Country
You need to sign in or create an account to save a job.

Job Details

The Quality Sr. Specialist II will organize and execute aspects of GMP implementation at the East Norriton manufacturing facility. The successful candidate will possess an understanding of cGMP, specifically building and maintaining quality systems in support of sterile/gene therapy/cell therapy manufacturing. In addition, the ideal candidate must have a proven track record self-situational leadership by way of project leadership or direct supervision of staff.

Job Responsibilities

  • 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 manufacturing and testing operations will comply with all US and International regulatory expectations.

  • Serve as a subject matter expert in GMP and provide technical expertise for QA operations.

  • Coordinate and execute QA support activities within Manufacturing Operations.

  • Review deviations, change controls and/or CAPAs, as needed.

  • Review batches manufactured at East Norriton, as needed.

  • Author and review technical documents including but not limited to SOPs, various quality reports.

  • Release batches manufactured at East Norriton, as needed.

  • Managing the Materials Release Program and escalating issues, as needed.

  • Participate in computer system validation activities, as needed.

  • Mentor, coach and train Quality Associates in the QA Operations Team

Preferred Experience, Education & Qualifications

  • B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).

  • 7-10 years relevant life sciences quality experience within quality and/or quality related functions.

  • Demonstrated track record with the successful support of GMP manufacturing and testing environments.

  • Demonstrated quality experience and the ability to collaborate with and effectively influence others.

  • Demonstrate experience with gowning and following aseptic behaviors.

  • Specific experience with aseptic, cell therapy and/or viral vector manufacturing strongly preferred.

  • Comfortable in a fast-paced, collaborative environment, working with minimal direction and able to adjust workload based upon changing priorities.

  • Familiarity with electronic quality systems/software applications.

  • Familiarity with electronic laboratory and manufacturing execution systems.

  • Working knowledge of GLP/GCP and GxP Regulatory requirements.

  • Experience in preparation and participation in regulatory authority plant/site inspections.

  • Experience supporting biologics manufacturing preferred.

Other Ideal Personal Characteristics:

  • Comfortable in a fast-paced, collaborative company environment, working with minimal direction and able to adjust workload based upon changing priorities.

  • Excellent oral and written communication skills.

  • Performs with Integrity.

  • Ability to collaborate and manage conflict in a fast-pace environment, working across functions.

  • Experience in application of lean methodologies and operational excellence to continuously improve.

#LI-RF1

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