Quality Assurance Specialist II (2 positions) job vacancy in Johnson & Johnson (Titusville, NJ)

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Company name : Johnson & Johnson
Location : Titusville, NJ
Position : Quality Assurance Specialist II (2 positions)

Description :
Janssen Supply Group, a member of Johnson & Johnson’s family of Companies, is recruiting for a Quality Assurance Specialist II (2 positions).
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group is part of the Janssen Pharmaceutical Companies.
Are you interested in making a difference in a thriving diverse company culture, that celebrates the uniqueness of our employees and is committed to inclusion? Apply today for this exciting opportunity!
In this role the Quality Assurance Specialist II will support stability site efforts to remain compliant with corporate and regulatory requirements. They are responsible for ensuring the Janssen US Stability sites maintain a state of inspection readiness through audits and by assuring compliance with regulatory and J&J requirements. Quality Assurance maintains a high level of quality knowledge with understanding of the quality and technical content of reports, investigations, and corrective and preventative actions that are documented by the group.
You will:

Maintain inspection readiness system and activities for the site
Participate in quality audits, inspection activities and responses
Draft, edit, review and approve department standard operating procedures (SOPs) and work instructions (WIs)
Successfully complete regulatory and job training requirements
Provide training for Quality concepts or systems
Responsible for assuring compliance to all relevant regulatory requirements (e.g., global cGMPs, DEA, EH&S) is monitored and gaps are mitigated
Coordinate, maintain, track, monitor, report and drive quality metrics
Monitor non-conformance and commitment data for trends
Assemble information (i.e., builds charts, graphs, etc.), participates in Site Management Reviews (SMR) and tracks action items to closure
Escalate issue to management in timely manner and works with management to address and remediate issues
Likely approve (or develop) cGMP training materials/plans for functional areas within site Stability Operations
Likely participate in quality issues/investigations as an SME or perform Quality review and approval of records


A Bachelor’s Degree is required. Bachelor’s Degree in Science or related field is preferred.
Minimum of 2 years of related work experience is required.
Knowledge and understanding of current Good Manufacturing Practices (cGMP) is required
Basic knowledge of analytical technologies used in a Quality Control Stability Laboratory is required
Knowledge of global regulatory and compendial (USP, EP, JP, etc.) requirements is required
Ability to participate and lead an individual project with minimal guidance from supervision/management in the training and document management space.
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) is required
Ability to influence others successfully
Proficient with Quality Systems for investigations/CAPA management, change control, training and document management (e.g., Trackwise, ComplianceWire, SUMMIT, TruVault) is required
Ability to write and/or effectively review documents for Good Document Practices (GDP)is required
Laboratory Equipment qualification experience is preferred
Knowledge of regulatory compliance is preferred
This position requires the availability to travel up 10% of the time.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]

Primary Location
United States-New Jersey-Titusville-1125 Trenton Harbourton Road


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