Sr Sterility Assurance Specialist

Eastridge Workforce Solutions; Mahwah (NJ); Sur place; USD 55 000 - 78 000; Plein temps

Résumé du poste

Eastridge Workforce Solutions is seeking a Senior Sterility Assurance Specialist (Microbiology & Sterilization) for an onsite role in Mahwah, NJ. The contract position focuses on sterilization, microbiology support, and product transfers for orthopedic devices.

You will author and review protocols, validate documents, and coordinate with labs and contract sterilizers while ensuring regulatory compliance in a validated environment.

Qualifications

• 2-4 years of microbiology, sterilization, or sterility assurance experience for sterile products in a regulated setting.
• Experience with sterilization validation, microbiological testing, and writing protocols and reports.

Responsabilités

• Support sterilization process validations and microbiological assessments for a product transfer
• Author, review, and approve protocols, validation documents, and final reports
• Coordinate with cross-functional teams, outside labs, contract sterilizers, and suppliers
• Conduct or coordinate environmental monitoring testing and trend the results
• Support investigations of out-of-specification results and maintain lab equipment and records

Connaissances

Microbiology & Sterility experience

Sterilization validation

Protocols and reports writing

Formation

Bachelor's degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or related science

Description du poste

Senior Sterility Assurance Specialist (Microbiology & Sterilization)

Job Snapshot

• Location: Mahwah, NJ | Onsite
• Pay: $48/hour
• Employment Type: Contract
• Work Type: Full-time
• Experience Level: Mid Level
• Duration: 18 months

Opportunity Summary

Join a global medical technology leader and support the sterilization and microbiology work behind its orthopedic products. In this onsite role in Mahwah, NJ, you will help with a product transfer, write validation documents, and monitor cleanroom quality.

Responsibilities

• Support sterilization process validations and microbiological assessments for a product transfer
• Author, review, and approve protocols, validation documents, and final reports
• Coordinate with cross-functional teams, outside labs, contract sterilizers, and suppliers
• Conduct or coordinate environmental monitoring testing and trend the results
• Support investigations of out-of-specification results and maintain lab equipment and records

Qualifications

Required

• Bachelor's degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or a related science
• 2-4 years of microbiology, sterilization, or sterility assurance experience for sterile products in a regulated setting
• Experience with sterilization validation, microbiological testing, and writing protocols and reports

Preferred

• Knowledge of ISO 11135, ISO 11137, AAMI guidance, FDA requirements, and EU MDR
• Experience with product or site transfers and working with contract sterilizers and outside labs
• Experience with environmental or water monitoring programs and trending

Why Join Us

• Onsite role in Mahwah, NJ
• Work on a product transfer project for orthopedic medical devices
• Build in-demand sterilization and microbiology skills in a regulated industry
• Collaborate with quality, manufacturing, and external lab partners

Benefits

Eastridge Workforce Solutions offers the following benefits, subject to applicable eligibility requirements. Use this link https://applicantcenterstorage.blob.core.windows.net/public-documents/EWSb1cb390e-729b-47eb-ab2f-b92adafbdd07-2024EplicaBenefitSummaryTempExternal.pdf to learn more about benefits available to Eastridge’s temporary employees. Due to the varying length(s) of temporary assignments, Eastridge Workforce Solutions’ Temporary Staff are not eligible for paid time off, unless required by applicable state law in which the position is based. However, from time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Disclaimer: The compensation and benefits information in this posting represents Eastridge’s good faith and reasonable estimate of what it might pay for this position. Eastridge reserves the right to modify this information at any time, subject to applicable law.

Equal Opportunity Employer

Eastridge Workforce Solutions is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity, and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, gender expression, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Eastridge Workforce Solutions also prohibits harassment or retaliation of applicants or employees based on any of these protected categories. It is our policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.

Please note that Eastridge is unable to provide visa sponsorship to applicants.

Background Checks

Certain clients require Eastridge Workforce Solutions to perform background checks. Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the California Fair Chance Act, the Los Angeles City Fair Chance Ordinance, Los Angeles County Fair Chance Ordinance for Employers, and the San Francisco Fair Chance Ordinance.

Massachusetts Candidates

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Privacy

Information collected and processed as part of your candidate profile, job application, resume, and/or any other information you choose to submit is subject to Eastridge’s Privacy Policy: https://www.eastridge.com/privacy-policy , as well as Eastridge’s Pre-Use Notice of Collection and Automated Decision-Making Technologies: https://www.eastridge.com/data-collection-notice .

By applying for this position, you consent to being contacted by Eastridge Workforce Solutions and its agents or authorized service providers regarding employment opportunities, assignments, and the recruiting process. Communications may be by phone call, AI-assisted or AI-generated phone call (where permitted by law), automated text message (SMS), or email.

The purposes for these communications may include, but are not limited to, confirming your interest in available opportunities, scheduling interviews, conducting initial screening conversations, and collecting information relevant to your application.

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