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Johnson & Johnson · 1 month ago

Senior Supervisor, QA Microbiology

Raritan, New Jersey, United States of America

Full-time

Onsite

Mid, Senior Level

$91K/yr - $147K/yr

6+ years exp

Johnson & Johnson is a leader in healthcare innovation, committed to creating a world without disease. The Senior Supervisor, Quality Assurance Microbiology will oversee quality assurance activities in the CAR-T Manufacturing department, ensuring compliance with cGMP and J&J requirements while managing staff performance and developing aseptic procedures.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Manage Aseptic Process Observation program and schedule manufacturing floor surveillance

Demonstrate aseptic techniques to be performed for crucial process steps through instructor-led trainings and awareness sessions

Support continuous optimization of the microbiological control strategy maintaining consistency with cGMP and Janssen requirements

Communicate key critical inputs to site environmental monitoring program

Actively support Process microbiological investigations, completion of corrective and preventive actions, internal/external audits and Quality risk assessments

Support the identification of risks and opportunities in relation to contamination control in the manufacturing environment and assist in follow-up initiatives for improvement in close collaboration with operators, QC and operations management; perform walkdowns to monitor the team’s performance

Support APS team regarding strategy and review/approval of site qualification activities

Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable Pharmacopeia while remaining current in on-the-job training requirements

Qualification

Microbiological industry experienceAseptic processing knowledgePeople management experienceQuality systems experienceCGMP regulations knowledgeWritten communication skillsVerbal communication skillsLeadership experience

Required

Minimum of a Bachelor's or equivalent university degree required; Engineering, Science, or equivalent technical subject area preferred

Minimum six (6) years of relevant work experience

Microbiological, Biological, and/or Pharmaceutical industry experience

Knowledge of or experience with aseptic processing in ISO 5 biosafety cabinets

People management or leadership experience (direct or indirect reports)

Experience working with Quality systems

Proficient written and verbal communication skills, with the ability to effectively summarize and present results

Preferred

Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices (GTP)

Experience working in an aseptic manufacturing facility

Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development

Benefits

Medical

Dental

Vision

Life insurance

Short- and long-term disability

Business accident insurance

Group legal insurance

Consolidated retirement plan (pension)

Savings plan (401(k))

Vacation –120 hours per calendar year

Sick time - 40 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

Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member

Caregiver Leave – 10 days

Volunteer Leave – 4 days

Military Spouse Time-Off – 80 hours

Company

Johnson & Johnson

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)