MQSA Associate Scientist
Posted on: 6 May 2024
West Chester, PA
Job Description
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
New Brunswick, New Jersey
Johnson & Johnson, together with its subsidiaries, researches and develops, manufactures, and sells various products in the health care field worldwide. It operates in three segments: Consumer, Pharmaceutical, and Medical Devices. The Consumer segment offers baby care products under the JOHNSON’S brand; oral care products under the LISTERINE brand; beauty products under the AVEENO, CLEAN & CLEAR, DABAO, JOHNSON’S Adult, LE PETITE MARSEILLAIS, NEUTROGENA, and OGX brands; over-the-counter medicines, including acetaminophen products under the TYLENOL brand; cold, flu, and allergy products under the SUDAFED brand; allergy products under the BENADRYL and ZYRTEC brands; ibuprofen products under the MOTRIN IB brand; and acid reflux products under the PEPCID brand. This segment also provides women’s health products, such as sanitary pads and tampons under the STAYFREE, CAREFREE, and o.b. brands; wound care products comprising adhesive bandages under the BAND-AID brand; and first aid products under the NEOSPORIN brand.
The Pharmaceutical segment offers products in various therapeutic areas, including immunology, infectious diseases, neuroscience, oncology, pulmonary hypertension, and cardiovascular and metabolic diseases. The Medical Devices segment provides orthopedic products; general surgery, biosurgical, endomechanical, and energy products; electrophysiology products to treat cardiovascular diseases; sterilization and disinfection products to reduce surgical infection; diabetes care products; and vision care products, such as disposable contact lenses and ophthalmic products related to cataract and laser refractive surgery.
The company markets its products to general public, and retail outlets and distributors, as well as distributes directly to wholesalers, hospitals, and health care professionals for prescription use. It has research and collaboration alliance with Morphic Therapeutic. The company was incorporated in 1887 and is based in New Brunswick, New Jersey.
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IndustryManufacturing
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No. of Employees135,100
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Website
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Jobs Posted747
