Quality Control Analyst, Critical Reagants
biopharma asiaRaritan, NJ
$65,000.00 - $104,650.00
APPLY (opens in a new tab)Quality Control Analyst, Critical Reagants
biopharma asiaRaritan, NJSenior L5
$65,000.00 - $104,650.00
In-Vitro Diagnostic Substance ManufacturingResearch and Development in BiotechnologyBiological Product Manufacturing
APPLY NOW (opens in a new tab)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:
Johnson & Johnson is currently recruiting for a Quality Control Analyst, CAR-T Critical Reagents! This position will be located in Raritan, NJ.
Johnson & Johnson Innovative Medicine and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in the manufacturing of our pharmaceutical products?
The Quality Control (QC) Analyst is responsible for preparing and conducting qualification testing of critical reagents used by the QC laboratories. They are responsible for ensuring testing is completed in adherence with all applicable procedures, standards, and GMP regulations.
Key Responsibilities:
Conduct analytical testing to qualify critical reagents used in the CAR-T QC laboratories
Perform analytical testing in compliance with all applicable procedures, GMP, and GDP regulations
Use eLIMS or paper records to document execution of testing
Ensure a safe work environment by following guidelines in environmental, health, and safety regulations
Perform peer review of laboratory data
Prepare qualification documentation and issue Certificate of Analysis
Author and updateSOPs, WIs, and Protocols using the Document Management System
Support laboratory related investigation records and CAPAs
Assist in the execution of internal audits
Provide input to functional laboratory meetings
Provide input and take actions as a QC representative at cross-functional meetings
Qualifications: Education
Minimum of a Bachelor's or equivalent University Degree required; focused degree in Biology, Biochemistry, or related scientific field is preferred
Experience and Skills
Required
Minimum two (2) years of relevant work experience
Knowledge of cGMP regulations and Good Documentation Practices (GDP)
Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
Excellent written and verbal communication skills
Preferred
Experience in reagent qualification
Experience in a Quality Control setting
Experience within Biopharmaceutical or Pharmaceutical industry
Basic knowledge of compendial (e.g., USP, EP, JP, etc.) requirements pertaining to their functional area of QC
Work experience in Cell and/or Gene Therapy
Other
This is Monday-Friday shift role, hours are 8AM-4PM, subject to be adjusted in the even of business need, occasional support on the weekends or holidays
May require up to 10% domestic travel to regional sites
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.
The anticipated base pay range for this position
$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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Matching similar jobs
Level
Senior L5
Salary
$65,000.00 - $104,650.00
Location
Raritan, NJ
Occupation
Quality Control Analysts
Industry
In-Vitro Diagnostic Substance Manufacturing
Posted
2 days ago