Quality Engineer I, Biologics Analytical Services
About The Position
Quality Engineer I, Biologics Analytical Services Position Summary Shift: Monday – Friday 8am-4:30pm 100% on-site Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Quality Engineer I, Biologics Analytical Services will provide technical and regulatory expertise to the management of all Quality processes to ensure patient safety, regulatory compliance, and inspection readiness. The Quality Engineer works with cross-functional teams to drive continuous improvement in biotechnological manufacturing and development processes.
Requirements
- BS or BA in Related Field and 3+ years of Scientific or Quality Assurance/Quality Control Experience
- Experience in US FDA GMP, ISO standards, as well as, comparable international regulatory agency requirements for investigations
- Experience in regulated industry and laboratory analysis
- Experience with ownership of Quality sub-systems
- Strict attention to detail required.
- Excellent problem-solving skills.
- Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time
Responsibilities
- Review and manage quality investigations including OOS, OOT, anomalous events, and deviations from biologics manufacturing.
- Evaluate issues for risk, assess product history, and identify trends or potential root causes.
- Collaborate with cross‑functional teams to resolve investigations and determine business or regulatory impact.
- Identify and support corrective and preventive actions (CAPAs) to drive investigation closure.
- Ensure investigations and required reports are completed accurately and within required timelines.
- Review processes, procedural changes, and materials for compliance with FDA, MHRA, WHO, QSR/cGMP, ISO, and other regulatory requirements.
- Provide technical input for deviations, non‑conformances, and overall quality system improvements.
- Represent the company during regulatory inspections and ensure inspection readiness.
- Communicate clearly with internal and external partners and maintain strong organizational and prioritization skills.
Benefits
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
