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Featured Employers
Lead Analyst Quality Assurance
Company: Johnson & Johnson
Location: Titusville, NJ
Employment Type: Full Time
Date Posted: 05/21/2022
Expire Date: 10/06/2022
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Computers, Software, Finance/Economics, Information Technology, Manufacturing and Production, Quality Control
Job Description
Lead Analyst Quality Assurance

Janssen Supply Group, a member of Johnson & Johnson's family of Companies, is recruiting for a Lead Analyst Quality Assurance.

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 Lead Analyst Quality Assurance 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:

  • Provide Quality review and guidance associated with investigations, change controls, protocols, reports, project planning and site procedures
  • Act as a subject matter expert (SME) for Quality-focused systems/projects
  • Provide Quality/Compliance guidance and recommendations to site personnel. Serve as subject matter expert within Stability Operations
  • Carrie out duties in compliance with all local, state and federal regulations and guidelines including FDA, EMA, EPA, DEA, and OSHA
  • Comply with all company and site policies, standards and procedures. Proactively evaluates and facilitates remediation of compliance risks
  • Maintains inspection readiness system and activities for the site. Participates in quality audits, inspection activities and responses
  • Successfully complete regulatory and job training requirements. Provides training for Quality concepts or systems
  • Assure compliance to all relevant regulatory requirements (e.g., global cGMPs, DEA, EH&S) is monitored and gaps are mitigated
  • Manages timeliness of local investigations, CPA, Change Controls (e.g., tracks open records and assures closure)
  • Escalate issues to management in timely manner and works with management to address and remediate issues
  • Monitor/track changes in regulatory environment (e.g., compendia, regulations/directives, guidance documents, global standards) and assures impact of the changes to Stability Operations are assessed by appropriate SME and CAPA implemented, as needed
  • Interact with Health Authorities during inspections and leads discussions demonstrating a proficiency of stability quality systems, products, and technologies
  • Leads teams to improve compliance processes consistently between sites. Responsible for training new employees and providing mentorship, coaching, and support as needed

Qualifications
  • A Bachelor’s Degree is required. Bachelor’s Degree in Science or related field is preferred.
  • Minimum of 6 years of regulated industry 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 manage an individual project with minimal guidance from supervision/management
  • Ability to read and interpret documents such as standard SOPs, work instructions, test methods and protocols is required
  • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) is required
  • Ability to makes GMP decisions both independently and with occasional guidance from QA supervision is required.
  • Ability to influence others successfully
  • Understanding of equipment qualification and computerized system validation (CSV) processes and requirements is required
  • Understanding of analytical method validation and transfer processes/requirements is required
  • 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/critique technical documents such as lab investigations with analytical and regulatory content as it relates to stability operations is required
  • Laboratory Equipment qualification experience is preferred
  • Experience commissioning and decommissioning of Lab equipment is preferred
  • Experience interacting with a regulatory body i.e., FDA, etc. 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
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality
Requisition ID
2206040668W
Contact Information
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