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**Job Function: **
Quality
**Job Sub Function: **
Quality Control
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America
Job Description:
J&J Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control - Microbiology LVV Manufacturing. This position will be located in Raritan, NJ.
Department Overview
At J&J Innovative Medicine, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are J&J Innovative Medicine. We collaborate with the world for the healthof everyone in it. Learn more at www.jnj.com/innovativemedicine.
Key Responsibilities
- Responsible for completing QC testing and environmental monitoring related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
- Create, review and approve QC documents SOP's, WI's, FRM's.
- Support Aseptic Process Simulations and visual inspections.
- Maintain Grade B/C gowning.
- Perform Environmental Monitoring and Critical Utility Sampling.
- Perform release assays: Mycoplasma, Endotoxin and Sterility (BAC-T).
- Perform Growth promotion, Subculture, Gram Stain and Microbial Identifications.
- Perform peer review/approval of laboratory data.
- Utilize electronic systems for execution/documentation of testing.
- Perform tasks in a manner consistent with safety policies, quality systems and cGMP requirements.
- Train QC analysts, operators or other employees.
- Other duties assigned as necessary.
- Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations and Analytical/Process Development.
- Available to work off hours or on weekends- dependent on business needs.
Qualifications:
Education:
A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required or a minimum of four (4) years of relevant work experience within the biological and/or pharmaceutical industry with relevant micro experience related to manufacturing is required, preferably in a Quality Control setting.
Key Competencies/Skills/Requirements
- Aseptic processing in ISO 5 clean room and biosafety cabinets.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products.
- Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment for microbiological testing/assays. (Endotoxin, EM, Bioburden).
- Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC Microbiology.
- Comprehensive knowledge of trending using statistical analysis.
- Ability to pay attention to details and follow the procedures.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.
- Proficiency in computer systems including LIMS or equivalent.
- The successful candidate must maintain written records of work in the form of notebooks, technical reports and protocols.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
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. #CAR-T
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$65,000.00 - $104,650.00
Additional Description for Pay Transparency:
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