Senior Analyst, Quality Systems

Johnson & Johnson Innovative Medicine; Raritan (NJ); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson is currently recruiting a Senior Analyst, Quality Systems to be located in Raritan, NJ. This role focuses on maintaining and improving quality systems, documents, data integrity, and cGMP compliance within the Advanced Therapies and Innovative Medicine teams.

You will collaborate across global sites, support audits and investigations, and lead selected projects through to closure while updating SOPs and aligning local and global processes.

Qualifications

• Minimum 4 years of related work experience.
• Experience in Quality Assurance/Quality Systems.
• Knowledge of cGMP regulations and FDA/EU guidance.
• Strong written and verbal communication skills in English.

Responsibilities

• Provide preliminary guidance and execute quality system activities, including but not limited to Document/Records Management and Data Integrity.
• Act as a liaison between Raritan Advanced Therapies (AT) site and AT platform/Innovative Medicine level activities.
• Support document lifecycle at Raritan AT.
• Perform Raritan AT superuser activities.
• Elevate identified quality systems risks to senior management.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGxP requirements.
• Actively assist in audit activities, Investigations and Change Controls.
• Identify improvement opportunities for quality systems activities.
• Participate in department optimization effort, take the lead on selected projects assignments following them through closure.
• Update Standard Operating Procedures or related documents as needed.
• Drive alignment and efficiencies between local and global processes through building positive relationships to meet unified business objectives.
• Other duties can be assigned to support business continuity.

Skills

Quality Systems

cGMP knowledge

Written and verbal English

Global collaboration

Education

Bachelor’s degree in engineering or science

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 Systems

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Analyst, Quality Systems. This position will be located in Raritan, NJ.

Key Responsibilities:

• Provide preliminary guidance and execute quality system activities, including but not limited to Document/Records Management and Data Integrity.
• Act as a liaison between Raritan Advanced Therapies (AT) site and AT platform/Innovative Medicine level activities.
• Support document lifecycle at Raritan AT.
• Perform Raritan AT superuser activities.
• Elevate identified quality systems risks to senior management.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGxP requirements.
• Actively assist in audit activities, Investigations and Change Controls.
• Identify improvement opportunities for quality systems activities.
• Participate in department optimization effort, take the lead on selected projects assignments following them through closure.
• Update Standard Operating Procedures or related documents as needed.
• Drive alignment and efficiencies between local and global processes through building positive relationships to meet unified business objectives.
• Other duties can be assigned to support business continuity.

Qualifications:

Education:

Minimum of a bachelor’s degree in engineering, Science or equivalent technical subject area is required

Experience and Skills:

Required:

• Minimum 4 years of related work experience
• Experience in Quality Assurance/ Quality Systems
• Knowledge of cGMP regulations and FDA/EU guidance
• Strong written and verbal communication skills in English

Strong collaboration and time management skills

• Ability to work in and support a global environment

Preferred:

Experience in a highly paced manufacturing environment is preferred

Other:

Requires ability and flexibility to provide occasional support at off-shift hours.

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.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$79,000.00 - $127,650.00

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