Product Quality Specialist
il y a 4 jours
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Product Quality Specialist, in the Stability Center of Excellence, PQM based out of Titusville, NJ or Beerse, Belgium.
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 small molecule products. Responsibility 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.
As a Product Quality Specialist, your main responsibilities include but are not limited to:
- Manage stability responsibilities for a set of small molecule products (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 filing as appropriate related to stability questions
- Responsible for stability Lifecycle management
- Supports PQI/PQL/PQO and Business Partners with stability related questions, as applicable
- 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 and issues are addressed in a timely manner.
- Be an active Member of Stability CoE by supporting departmental goals and identifying opportunities for improvement based on active work and prior experiences.
**Qualifications**:
- A minimum of a Bachelor’s degree with a major in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or equivalent university degree
- 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 the demonstrated ability to interact with various levels of the organization.
- 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.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
**Primary Location**
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
**Other Locations**
Europe/Middle East/Africa-Belgium-Antwerp-Beerse
**Organization**
JANSSEN SUPPLY GROUP, LLC (6046)
**Job Function**
Quality
**Requisition ID**
2206017620W
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