Job Function:
Quality
Job Sub Function:
Quality Control
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America
Job Description:
A candidate has been pre-identified for consideration. However, all applications will be considered.
We are searching for the best talent for an Quality ControlAnalyst based in Raritan, NJ.
The Quality Control 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.
Key Responsibilities:
Perform analytical testing and maintain a safe work environment in compliance with all applicable procedures, EHS, and GMP regulations.
Perform peer review and approval of laboratory data and logbooks.
Use electronic systems (e.g., LIMS, iLAB) for the execution and documentation of testing.
Build, review, and approve relevant QC documents, SOPs, and WIs.
Complete invalid assay and general laboratory investigation records, CAPAs, and change controls.
Support Health Authority inspections.
Provide input to functional laboratory meetings.
Qualifications:
Education:
A minimum of a Bachelor’s degree or equivalent university degree is required; an advanced degree (MSc., Ph.D.) or a focused degree in Biology, Biochemistry, Chemistry, or a related scientific field is preferred.
Experience and Skills:
Required:
A minimum of two (2) years of relevant work experience.
Experience performing one or more of the following cellular and/or molecular-based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or potency assays.
Experience within the biopharmaceutical or pharmaceutical industry.
Experience with aseptic processing in biosafety cabinets and/or ISO 5 cleanroom environments.
Demonstrated experience successfully working in an analyst role/level and proficiency using analytical methodologies within a functional laboratory.
Knowledge of cGMP regulations and Good Documentation Practices (GDP).
Experience with Quality Control document reviews and regulatory inspection processes.
Proficiency in technical writing (e.g., test methods, SOPs, protocols, etc.).
Excellent written and verbal communication skills.
Preferred:
Work experience in Cell and/or Gene Therapy or Biologics.
Basic knowledge of compendial requirements and standards (e.g., USP, EP, JP, etc.).
Experience with LIMS and SAP or equivalent systems.
Experience, training, or certification with Process Excellence tools and methodologies.
Other:
Requires the ability and flexibility to work 10-hour shifts between the operational hours of 8:00 AM – 6:00 PM (Sunday–Wednesday), and to provide occasional support on weekends or other shifts.
Requires the ability to meet physical demands, including lifting up to 20 lbs, and standing or sitting for extended periods in a laboratory setting; performing visual inspections of materials (e.g., color, appearance, particles); and documenting observations during laboratory testing.
Requires up to 5% domestic travel to other sites/locations.
#LI-Onsite
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 Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy
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)).
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
