Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Athens, Georgia, United States of America, Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:
Description:Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Specialist, External Quality (Synthetics)! This position can be performed at Raritan or Titusville, NJ, Malvern, Spring House or Horsham, PA & Athens, GA.
In this position you will provide end to end quality support for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.
Key Responsibilities:- Provide quality and technical support to ensure effective execution of quality systems at external manufacturing sites.
- Support the identification and resolution of quality issues and complaints, including review and approval of non-conformances and development of robust CAPA plans. Support the escalation and issue management processes.
- Review and approve quality systems documentation, including batch documentation and product disposition, change controls, manufacturing instructions, quality agreements, specifications, validation documentation, and technical studies.
- Monitor quality performance through key performance indicators; analyze data to identify risks and drive implementation of mitigation plans.
- Build relationships with internal and external partners to meet patient supply requirements.
- Support external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture. Support risk management initiatives necessary to improve performance. Write and implement quality procedures and work instructions.
- Collaborate to support health authority inspections and audits; monitor and follow-up on associated responses and commitments.
- Provide quality oversight for tech transfer and new product introduction activities. Support a variety of projects both internally and with external manufacturers.
- Act as a backup to External Quality account owners in support of external manufacturers as needed.
Qualifications:Education:
- A minimum of a Bachelor's or equivalent University degree is required with a focus in life science, engineering, physical science preferred.
Experience and Skills:Required:
- A minimum of 5 years working in a cGMP regulated environment.
- Experience supporting quality oversight for pharmaceutical (or equivalent) production, including manufacturing operations, cGMP compliance, and non-conformance investigation.
- Ability to work independently in support of a portfolio of products and external manufactures.
- Experience working on cross-functional project teams.
- Strong communication and influencing skills; demonstrates an ability to communicate at all levels of the organization.
Preferred:- Experience working with external partners.
- Experience with product transfer, new product introduction, medical devices, and combination products.
- Proficient in applying process excellence tools and methodologies.
Other:- This role may require up to 25% of domestic & international travel.
Required Skills:
Preferred Skills:
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)).
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
