Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Compliance Analyst II located in Spring House, PA.
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 Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Responsibilities include:
Provide guidance and support to laboratory staff on GxP documentation, study data and supporting data.
Work to ensure quality and compliance within Janssen BioTheraputics.
Lead teams to execute process improvements in compliance.
Work cross-functionally with internal partners to align and standardize best compliance practices.
Provide independent regulatory guidance to members within JBIO
Perform process and data review supporting non-clinical and clinical analysis in the GLP and GCP environment within JBio
Work independently, challenge the status quo, identify gaps and drive process improvements
Work cross-functionally to align GxP practices with other Janssen business partners.
Maintain the highest level of GxP compliance and evaluate department policies for efficiencies.
Ensure quality of and compliance to SOPs.
Contribute to Regulatory submissions.
Work cross-functionally to bridge gaps between groups within JBio
Lead the development of departmental SOPs and process improvements.
Assist in the preparation for internal and external audits.
Lead the development of data processing and handling procedures for the discovery team that meet DDI standards.
BS in Biological Sciences or Communications required. A Master’s degree or other advanced degree with a minimum of 3 years relevant pharmaceutical/scientific experience; or a Bachelor’s degree with a minimum of 5 years of relevant pharmaceutical/scientific experience is required.
- Strong oral and written communication skills is required.
- Attention to detail is required.
- Ability to function and potentially lead cross-functional teams is required.
- Organizes time well is required.
- Demonstrates learning agility is required.
- Builds solid and positive relationships with cross-functional team members is required.
- Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, networking) is required.
- Strong expertise in areas of GLP/GCP compliance is required.
- Experience with ELISA assays and LIGAND binding assays is preferred.
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
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)