CAR T Warehouse Change Control Analyst

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 are searching for the best talent for CAR-T Warehouse Change Control Analyst to be in Raritan New Jersey.

Purpose: The CAR T Warehouse Change Control Analyst supports organization Change activities and is responsible for assessing the changes needs impacts and lead implementation activities.

You will be responsible for:

• Support process changes involving the CAR-T Warehouse.
• Support the change control process.
• Identify the needs of the warehouse and submit the request for a change control.
• Act as change control champion by being responsible for the change control prior to Initiation through completion.
• Participate in change control meetings.
• Perform tasks in a manner consistent with the safety policies quality systems and cGMP requirements.
• Other duties will be assigned as needed.

Qualifications / Requirements:

Education:

• Minimum of a Bachelors is required

Experience and Skills:

Required:

• Minimum two (2) years of relevant work experience
• Experience in Quality Assurance Quality Systems or Compliance
• Confirmed experience supporting change controls
• Practical knowledge in current Good Manufacturing Practices
• Proficiency in Microsoft Office tools (Word Excel PowerPoint and Outlook)
• Experience with COMET or equivalent system
• Strong interpersonal written verbal communication skills and the ability to influence at all levels

Preferred:

• Experience with CAR-T cell and gene therapy
• Knowledge of National and International manufacturing regulatory requirements (e.g. FDA/EU)
• Familiarity with SAP MES (electronic batch records) or equivalent systems

Other:

• Requires ability and flexibility to accommodate shift schedule (if needed) and unplanned overtime (including nights and weekends) on little to no prior notice.

Additional Information:

The anticipated base pay range for this position is $51450 to $82110.

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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Companys 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. & 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 () 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 $51450 to $82110.

  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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys 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. Experience:

  IC