Product Quality Specialist

Johnson & Johnson Innovative Medicine; Titusville (NJ); On-site; USD 94,000 - 152,000; Full time

Benefits offered by this job

Vacation – 120 hours/year

Sick time – 40 hours/year (state-based

Holiday pay 13 days/year

Parental Leave – 480 hours

Job summary

Johnson & Johnson Innovative Medicine seeks a Product Quality Specialist based in Raritan, NJ or Titusville, NJ to own stability management across a portfolio through development to commercial stages.

The role requires 6-8 years in industry, a Bachelor's degree, and strong knowledge of stability regulations; opportunity to influence PQS processes and mentor team members.

Qualifications

• 6-8 years of industry experience.
• Clear knowledge of stability related regs.
• Proficient with Microsoft Office and web-based collaboration tools.

Responsibilities

• End-to-end accountability for stability management from late-stage development through full commercial lifecycle for a product portfolio.
• Provide expertise in stability with a focus on regulatory compliance and data integrity.
• Mentor CoE members and participate in cross-functional meetings as needed.
• Support stability-related escalations and regulatory filings with stability data.

Education

Bachelor’s Degree

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 Assurance

Job Category

Professional

All Job Posting Locations

Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description

We are searching for the best talent for a Product Quality Specialist to be based in Raritan, NJ or Titusville, NJ.

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 https://www.jnj.com/innovative-medicine

You Will Be Responsible For

• Has end-to-end accountability for the stability management and oversight from late stage development through full commercial lifecycle for a portfolio of products.
• Responsible for product quality related activities with a specific expertise in stability.
• Supporting the work of PQI/PQO/PQL and actively contributing to overall smooth functioning of the Stability CoE
• Be expert in specific areas of stability management
• Operate independent in the PQS role with minimal support
• Support departmental goals and activities
• PQS for Product families that are highly complex or L&G of high value requiring interactions with multiple functions and teams.
• Identify opportunities for improvement
• Mentor less seasoned members of CoE
• Participate in cross-functional meetings as needed
• Support stability related escalations as needed
• Support regulatory filings with stability information/data.
• Responsible for stability Protocols/reports
• Stability SME for assigned product, manage temp excursions, CC etc.

Qualifications/Requirements

• 6-8 years of industry experience
• Education Bachelor’s Degree
• Ability to work with others in a team environment
• Ability to manage individual assignments with minimal guidance
• Ability to read and interpret documents such as SOPs, work instructions, protocols
• Clear knowledge of stability related regs
• Proficient with using Microsoft office applications and web-based collaborative applications

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, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

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)).

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