MQSA Associate Scientist

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity

West Chester (Chester County)

On-site

USD 65,000 - 95,000

Full time

9 days ago

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Job summary

Johnson & Johnson is seeking an MQSA Associate Scientist to join its West Chester, PA team, with potential placement in Palm Beach Gardens, FL. The role focuses on implementing and maintaining sterilization processes to ensure product safety and efficacy. You will collaborate with scientists to uphold stringent regulatory and quality standards.

The position involves endotoxin testing, data trending, OOS monitoring, and supporting GMP/GDP compliance within a dynamic MedTech environment.

Qualifications

Bachelor’s degree in Microbiology, Biomedical Science, Engineering, Sterility Assurance, Food Science or related field preferred.
Minimum of 2 years of sterilization/microbiological experience in medical device/pharma/food industries.
Solid understanding of FDA QSR, CMDR, MDD, ISO13485, ISO14971 and ISO9001 strongly preferred.

Responsibilities

Supports endotoxin testing and dose audit activities 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 microbiological quality requirements are met per customer and regulatory needs.
Supports requalification activities to ensure compliant Ethylene Oxide sterilization program.
Preparation and routing of documents for change request/change order processes.
Compliance with GMP/GDP requirements and guidelines.

Skills

Fluent in English

Strong teamwork

Analytical thinking

Attention to detail

Education

Bachelor’s degree in Microbiology/Biomedical Science/Engineering/Sterility Assurance

Tools

MS Office

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality Job Sub Function: R&D/Scientific Quality Job Category: Business Enablement/Support All Job Posting Locations: Palm Beach Gardens, Florida, United States of America, West Chester, Pennsylvania, United States of America.

Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 at https://www.jnj.com/. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. We are searching for the best talent for MQSA Associate Scientist, located in West Chester, PA USA or Palm Beach Gardens, FL USA. As an MQSA Associate 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:

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.

Qualifications Education:

Educational requirement: a Bachelor’s degree in Microbiology, Biomedical Science, Engineering, Sterility Assurance, Food Science or related field is preferred.
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 and Skills:

Required: 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.
Preferred: Experience writing standard operating procedures, protocols, and test reports.
Knowledge of EU, FDA, cGMP and cGLP regulations is strongly preferred.

Other:

Up to 5% domestic travel may be required.

Johnson & Johnson is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills: Preferred Skills: