Senior Specialist, Quality Assurance
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 Job Summary The Senior Quality Assurance Specialist (Quality Control Support) will organize and execute aspects of cGMP 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 gene therapy/cell therapy manufacturing.
Requirements
- Relevant life sciences quality experience within quality and/or quality related functions.
- Demonstrated track record supporting quality operations and/or systems.
- Demonstrated quality experience and the ability to collaborate with and effectively influence others.
Nice To Haves
- B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).
- Five years of specific experience with cell therapy and/or viral vector assays / methods strongly preferred.
- Experience with electronic laboratory information management systems.
- Familiarity with electronic quality systems/software applications.
- Familiarity with manufacturing execution systems.
- Working knowledge of GLP/GCP and GxP Regulatory requirements.
- Experience in preparation and participation in regulatory authority plant/site inspections.
- 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-paced environment, working across functions.
- Experience in application of lean methodologies and operational excellence to continuously improve.
- Proficiency in creating high quality procedures that are easy to read and understand.
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.
- Review and approve deviations, change controls, CAPAs and other applicable quality records.
- Review and approve laboratory investigations.
- Conduct quality oversight, review and approve of method qualifications and validations.
- Author, review, and approve technical documents including but not limited to SOPs, various quality reports and assessments.
- Review and approve Test Methods and SOPs associated with Quality Control, as needed.
- Approval of drug product Certificate of Analysis (CoA/CoT) required for the manufacturing process.
- Participate in the oversight and changes to the LIMS environment.
- Quality oversight of the GMP Material Enrollment Program, inclusive of supplier quality tasks for the East Norriton site.
- Release of GMP materials utilized in the manufacturing process.
- Manages client communications, escalations, and documentation, as needed.
- Supports audits/inspections for the East Norriton site, as needed.
- Mentor, coach and train Quality Associates in the QA Operations Team and other departments.
- Completes qualified program requirements necessary to train other employees.
- Support Quality Assurance team members, as needed.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
