Lead Quality Assurance Specialist
Full Time
East Norriton, PA
$95,000 - $132,500 a year
Posted
Job description
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
The Lead Quality Specialist 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.
- Review documentation for manufacturing activities including but not limited to executed batch records and master batch records.
- Independently performs batch record review.
- Releases batches manufactured at East Norriton.
- Reviews and approves the certificate of analysis.
- Review deviations, OOSs, change controls and/or CAPAs, as needed.
- Author and review technical documents including but not limited to SOPs, risk assessments, various quality reports.
- Compile and report performance metrics for batch review and release.
- Understand risks and delays to batch release and communicate appropriately.
- 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).
- Demonstrated quality experience and the ability to collaborate with and effectively influence others.
- 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.
Minimum Qualifications
- 7-10 years of 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.
- Experience with a quality batch review and batch release.
- Experience with aseptic, cell therapy and/or viral vector manufacturing is strongly preferred.
- Experience supporting biologics manufacturing.
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-paced environment, working across functions.
- Experience in the application of lean methodologies and operational excellence to continuously improve.
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