Staff Scientist, Microbiology Quality & Sterility Assurance – Orthopedics
OneTrust
full-time
Posted on:
Location Type: Hybrid
Location: Raynham • Massachusetts • United States
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Salary
💰 $109,000 - $174,800 per year
Job Level
About the role
- Responsible for end-to-end implementation of projects associated with microbiological quality and sterility assurance across the make and product development teams for Orthopedics.
- Ensure that those programs are aligned with the overall J&J Microbiological Quality & Sterility Assurance programs.
- Serve as a technical leader in the areas of microbiological quality, sterilization, and reprocessing.
- May manage a team with partners to centrally support end to end microbiological quality.
- Set the strategic and tactical direction of the team through the application of technical knowledge and expertise in microbiological quality, and sterilization processing.
- Oversee partnerships for product development, make and the deliver quality organization.
- Responsible for compliance to applicable quality regulations and standards and serves as the site subject matter expert for MQSA.
Requirements
- A minimum of 4-6 years of related experience in a medical device and/or pharmaceutical industry in a GMP and/or ISO regulated environment.
- Experience managing a workplace in compliance with regulatory or company requirements.
- Ability to communicate science to line management on schedules and processing timetables to ensure timely completion.
- Demonstrate strong technical knowledge in microbiological testing and requirements: including cleaning validations, sterilization validations, routine microbiological and chemical contamination control requirements and reprocessing requirements for medical devices.
- Experience integrating new technologies and test methods into routine practice.
- Conducts technical assessments, evaluates suppliers' other contract services.
- Develop innovative ideas for process improvements.
- Interface with Regulatory Authorities during on-site inspections related to submissions.
- Lead MQ&SA remediation activities from audit findings.
- Participate as SME in audits internal/external.
- Ensure compliance with the team for a safe working environment.
- Support integration of new acquisitions relative to MQSA.
- Manage processes across multiple quality management systems to support the business.
- Demonstrates strong people leader and business acumen, this position may have direct reports.
- Proficiency in the English language (oral and written) is required.
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year.
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year.
- Holiday pay, including Floating Holidays –13 days per calendar year.
- Work, Personal and Family Time - up to 40 hours per calendar year.
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year.
- Caregiver Leave – 80 hours in a 52-week rolling period10 days.
- Volunteer Leave – 32 hours per calendar year.
- Military Spouse Time-Off – 80 hours per calendar year.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
microbiological qualitysterilizationreprocessingcleaning validationssterilization validationsmicrobiological testingchemical contamination controlGMPISOquality management systems
Soft Skills
technical leadershipcommunicationprocess improvementpeople leadershipbusiness acumen