Janssen Pharmaceuticals is recruiting for a Specialist, Quality Compliance DEA, located in Athens, GA!

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 Pharmaceuticals, Inc. is part of the Janssen Pharmaceutical Companies.

The Specialist, Quality Compliance DEA is responsible for handling of the Controlled Substance (CS) Program II & III and assure the overall company compliance within established current GMP guidelines / Controlled substances, corporate standard operating procedures, policies, rules and regulations. The successful candidate will support internal and external audits/inspections, support site projects related to control substances, and assist the Senior Compliance Specialist in the activities of the CS Team and CS global partners interactions as requested and within Company/FDA/GMP/DEA regulations.

Responsibilities:

• Assist in maintaining quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner.
• Support change control documentation and approval process.
• Assist in the development of corrective action plans and monitors implementation.
• Assist in conducting investigations, collects data, analyzes trends and prepares reports for assigned CS quality processes.
• Monitors trends, identifies issues, recommends, and implements appropriate actions.
• Assists in the development, implementation, and review of standard operating procedures for interactions with contract manufacturers supporting CS Operations.
• Support and assist in preparing controlled substances reports/documents.
• Support, review, evaluation and approval of SOP’s and Change Controls related to controlled substances.
• Manage all necessary licenses up to date e.g. DEA, ASSMCA, Department of Health, USDA, etc.
• Support the review and approval of NCR’s related to controlled substances products.
• Responsible for keeping up to date the NDA Submissions-related documentation.
• Acts as a compliance representative in plant wide project teams and New Products activities specially does relate to controlled substances.
• Enforce all products are manufactured and packaged under quality systems and procedures.
• Provides regulatory/Compliance guidance and leadership to support all company processes.
• Complies with the goals of the quality team and with overall business and process goals.
• Complies with Safety and Environmental procedures in all areas.

Qualifications

Qualifications:

• Bachelor’s degree required.
• 3+ years in the Compliance areas (Complaints, Internal Audits, Change Controls, NDA) within the pharmaceutical industry required; 5 years preferred.
• Oral and written communication skills in English required.
• Technical writing and documentation , problem solving, decision making, leadership, business and technical acumen, ability to facilitate and influence change required.
• Computer knowledge in Microsoft Software application is required.
• Knowledge in Controlled Substance remediation processes, DEA & Department of Justice legal agreements, Trackwise system, CS Metrics & Export Tools, ARCOS System, REACT System, and SAP System applications are strongly preferred.
• Read, interpret and analyze documents such as policies, procedures, manuals.
• Deal and solve simple to complex problems.
• Handle multiple priorities at the same time.
• Ability to travel up to 10%.

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 ( http://www.careers.jnj.com ).

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