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Mqsa Associate Scientist

2 months ago

West Chester, United States Johnson & Johnson Full time

**DePuy Synthes **, is recruiting for an **MQSA Associate Scientist **, located in **West Chester, PA.**

About Johnson & Johnson

**Job 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**
- 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 Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.