Location: Malvern,PA, USA
Requirements:
-A minimum of a bachelor's degree is required, preferably in Engineering, Science or equivalent technical discipline.
-5 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required
-Ability to maintain written records of work performed in paper-based and computerized quality systems is required.
-Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is required
-Knowledge and exposure to nonformences, CAPAs,
-Experience with Data Analytics
Preferred:
-Experience within Quality Risk Management
-Project management experience
Day to Day:
One of our large pharmaceutical clients is looking to hire a Quality Excellence Associate to join their growing team. This individual will be leading Continuous Improvement site initiatives that improve safety, improve overall quality of execution, increase process efficiencies, and reduce cycle time and cost. Main responsibilities will include, but are not limited to:
- Pull and analyze data from quality groups to prepare analyses and presentations, streamline processes, and develop insights for team meetings.
- Format all reporting/data sets for meeting agenda, prepare presentations, and upload CRB Minutes in EDMS.
- Combine weekly data to analyze and send out for review. Format all reporting for presentation and upload QSMR report into Truvault.
- Investigate Trend report to track deliverables, format report and upload in EDMS.
- Support development of Quality Risk Management Framework.
- Support Quality Systems Tasks e.g., Site Master File maintenance, Gap Assessments, Quality Agreements
Compensation:
$39-48
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.