- Supports endotoxin testing and dose audit activities for external suppliers by coordinating sample procurement, sterilization activities and laboratory testing.
- Preparation and evaluation of trending data. Increases awareness of out of specification (OOS) results.
- Works with Product Development Teams to ensure the microbiological quality requirements are established and met based upon the customer and regulatory needs.
- Supports the requalification activities needed to ensure a compliant Ethylene Oxide (EO) sterilization program.
- Preparation and routing of documents for the change request/change order processes.
- Compliance with GMP/GDP requirements and guidelines.
- Educational requirement:
- Minimum of 2 years of sterilization/microbiological experience in the medical device, pharmaceutical and/or food science industries.
- Solid understanding of applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO13485, ISO 14971 and ISO 9001 is strongly preferred.
- Experience in the field of microbiology or quality assurance, in the production of sterile products.
- Fluent in English
- MS Office skills
- Strong teamwork and interpersonal skills
- Analytical and critical thinking skills are essential with strict attention to detail.
- Experience writing standard operating procedures, protocols, and test reports.
- Knowledge of EU, FDA, cGMP and cGLP regulations is strongly preferred.
- Up to 5% domestic travel may be required.
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MQSA Associate Scientist - West Chester, United States - J&J Family of Companies
Description
MQSA Associate Scientist WDescription
DePuy Synthes , is recruiting for an
MQSA Associate Scientist , located in
West Chester, PA.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more atJob Summary
As an Associate Sterilization Scientist, you will join our dynamic team of experts in the field of sterilization. You will be responsible for implementing and maintaining sterilization processes to ensure the safety and quality of our products. Your work will contribute to attaining the highest standards of sterilization, preventing contamination, and ensuring product efficacy. While collaborating with a hard-working team of scientists, you will have the opportunity to work with innovative sterilization technologies
Key Responsibilities
Qualifications
Education:
Experience and Skills:
Required:
Preferred:
Other:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .
Primary Location NA-US-Pennsylvania-West Chester
Organization Medical Device Business Services, Inc (6029)
Job Function R&D/Scientific Quality
Req ID: W