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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:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Associate Analyst, Quality Control CAR-T to be in Raritan, NJ.

**Purpose:** The QC Associate Analyst is responsible for conducting biochemical, microbiological, and/or general testing of final product samples submitted to the QC laboratories. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 – 15 other Analysts within the functional laboratory of the Quality Control department.

You will be responsible for:

+ Lab support and maintenance

+ Sample handling (Supporting with the lifecycle of the samples outside of testing (Sample running-Disposal)

+ Accountable for the review of equipment logbooks

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

+ Responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP laboratory.

+ Ensure testing is completed in compliance with all applicable procedures, standards, and GMP regulations.

+ Perform peer review/approval of laboratory data.

+ Apply electronic systems (LIMS, MES) for execution and documentation of testing.

+ Supports process improvement teams.

Qualifications / Requirements:

Education:

+ A minimum of an Associates’s Degree in Engineering, Science or equivalent technical field is required.

Experience and Skills:

Required:

+ Minimum of (0-1) years of relevant work experience

+ Knowledge of cGMP regulations, Good Documentation Practices (GDP) and FDA/EU guidance related to manufacturing of cell-based products is required.

+ Experience within Biopharmaceutical or Pharmaceutical industry

+ Experience with aseptic processing in biosafety cabinets and/or ISO 5 clean room

+ Experience with Quality Control document reviews and regulatory inspection processes

+ Excellent written and verbal communication skills

+ Candidates must be able to accommodate shift schedule. Shifts may include weekend and evening work as required by the manufacturing process.

Preferred:

+ Experience in a Quality Control setting is preferred.

+ Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards

+ Experience with LIMs and SAP or equivalent systems

+ Basic understanding of routine and non-routine testing and sampling methods, techniques and related equipment is preferred.

Other:

+ **Requires** ability and flexibility to work 10-hour shifts between the operational hours of 8:00am - 6:00pm (Sunday - Wednesday), and provide occasional support on the weekends or other shifts

+ **Requires** the ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting), to perform visual inspections of materials (color, appearance, particles, etc.), and to document observations during laboratory testing

+ **Requires** up to 5% domestic travel to other sites/locations

_Additional Information:_

The anticipated base pay range for this position is $59,000 to $85,100.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. ·

+ Employees and/or eligible dependents may be 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.

+ Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

+ This position is eligible to participate in the Company’s long-term incentive program.

+ Employees are eligible for the following time off benefits:

+ Vacation – up to 120 hours per calendar year

+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

+ Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

+ Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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 and 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

The anticipated base pay range for this position is $59,000 to $85,100.

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. · • Employees and/or eligible dependents may be 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. • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). • This position is eligible to participate in the Company’s long-term incentive program. • Employees are eligible for the following time off benefits: • Vacation – up to 120 hours per calendar year • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year • Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.