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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub** **Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is recruiting for a Quality Control Analyst- Microbiology Lentiviral Vector (LVV). This position will be located in Raritan, NJ!

_At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at_ _https://www.jnj.com/_ _._

Position Summary:

The QC Analyst - Microbiology - is responsible for collaborating with the Operations Team to conduct environmental monitoring and gas sampling within the manufacturing facility. Additional responsibilities in the QC Laboratory include environmental monitoring plate reads, endotoxin testing, buffer sampling, gram stain, bioburden testing, shipping/receiving of equipment/materials and cleaning of the QC Laboratory space.

Key Responsibilities:

+ Participate in LVV manufacturing facility commissioning and qualification.

+ Participate in gown qualifications .

+ Perform Routine Environmental Monitoring of classified areas within the Raritan LVV Facility to include Grade A/B/C/D.

+ Perform compressed gas sampling in the LVV manufacturing facility.

+ Perform environmental monitoring plate reads.

+ Perform endotoxin/bioburden testing.

+ Create, review, and approve relevant QC documents, SOPs, and WIs.

+ Utilize electronic systems (eLIMS) for execution and documentation of testing.

+ Perform peer data review/approval of laboratory data.

+ Support and process APS/APQ units and visual inspection of components.

+ Initiate quality investigations or lab incidents related to microbiology.

+ Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Qualifications

Education:

Minimum of a Bachelor’s or equivalent degree required; focused degree in Biological Science or equivalent technical field preferred in Microbiology

Experience and Skills:

Required:

+ Minimum of (2) two years of experience in a QC role within the pharmaceutical or healthcare industry.

+ Proficient in microbiological testing techniques and methods.

+ Strong knowledge of cGMP regulations and industry standards.

+ Excellent attention to detail and ability to maintain strict adherence to protocols.

+ Exceptional problem-solving and decision-making skills.

+ Ability to effectively communicate and collaborate with cross-functional teams.

+ Physical requirements: ability to lift up to 50 lbs (23 kg) and stand for extended periods.

Preferred:

+ Experience with aseptic techniques and environmental monitoring.

+ Knowledge of statistical analysis and data interpretation.

+ Familiarity with Lean Six Sigma principles.

Other:

+ This position is anticipated to have up to 10% travel

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy

The anticipated base pay range for this position is :

$69,500-$102,350  USD$

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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 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 Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits