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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description: Analyst, Quality Control (P-23_E4)

Entry to developing individual contributor, who works under close supervision. Assists staff in various processes in the Quality Control function. Supports day-to-day laboratory activities such as sample management, supply ordering and receipt, and general housekeeping. Assists with analysis, qualification/validation activities, and lab investigations. Supports data review and metrics reporting. Executes continuous improvement projects with supervision. May execute testing under supervision.

Job Description

Assists laboratory staff with sample receipt, management of reagents and supplies, and general housekeeping. Tests samples of finished goods under general supervision. Applies developing knowledge of Quality Control standards to review results of quality analysis and report issues as required. Supports data review and analysis, and leads implementation of risk mitigations and continuous improvement initiatives under supervision. Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Major Responsibilities

• Lab support and maintenance

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

• Responsible 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.

Requirements:

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

• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.

• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.

• Knowledge of Good Manufacturing Practices is preferred.

• Experience with electronic systems such as (LIMS, MES) is preferred.

• Experience in a Quality Control setting is preferred.

• Excellent written and oral communication skill are

required

• Basic knowledge of routine and non-routine testing and sampling methods, techniques and related equipment is preferred.
• Candidates must be able to accommodate shift schedule. Shifts may include weekend and evening work as required by the manufacturing process.

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 :

$54,000.00 - $87,400.00

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)).

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

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

For additional general information on Company benefits, please go to:

• https://www.careers.jnj.com/employee-benefits