Job Function: Quality
Job Sub Function: Quality Assurance
Job Category:Professional
All Job Posting Locations:Horsham, Pennsylvania, United States of America, 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. 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
Purpose: The Product Quality Specialist, Stability CoE, has end-to-end accountability for the stability management and oversight from Late Stage Development through full commercialization lifecycle for a portfolio of products. Responsibility for product quality related activities with a specific expertise in stability including protocol and report generation. Supporting the work of PQI/PQO and actively contributing to overall smooth functioning of the Stability CoE.
You will be responsible for:- Stability POC for a set of products families (API and Drug Product)
- Oversight of Sample management for stability
- Author/oversight of stability Protocols and Reports in accordance with global SOPs including sampling strategy
- Support audits and filings as appropriate related to stability questions
- Responsible for stability Lifecycle management
- Supports PQI/PQO and Business Partners with stability related questions
- Support temperature excursions, change controls, stability notifications and escalations as applicable.
- Maintain stability statements for assigned products.
- Partner with Stability Labs as needed to ensure questions are addressed in a timely manner.
- Active Member of Stability CoE:
- Support departmental goals.
- Give input on topics raised in staff meetings to support continued improvement of stability processes.
Qualifications/Requirements:- Bachelor's degree with a major in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree is required.
- A minimum of 6 years of relevant experience is required
- A minimum of 4 years' experience in the pharmaceutical, biotechnology, or medical device industry is required (post graduate experience and/or education will count towards years of industry experience).
- Experience in API and drug product stability and business implications regarding stability decisions is desired.
- Understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management is required.
- Insight in pharmaceutical and/or chemical processes, product quality assurance/control, and product development and manufacturing is a plus.
- Demonstrated ability to work independently and in a team environment
- Relationship building as part of a team is required.
- Strong written and oral communication skills with various levels of the organization.
- Understanding of global regulatory requirements and guidelines applicable to pharmaceuticals, with the ability to apply GMP regulations.
- Must be flexible to accommodate US, EMEA and AP work schedules when vital, balancing work and personal time
- This position may require up to 5-10% domestic and international travel as business demands.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Belgium, Ireland, Italy, and Netherlands - Requisition Number: R-092525
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Required Skills:Preferred Skills:Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards
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
