Controlled Substance Specialist - 2306159239W

　　Description

　　Janssen Ortho LLC, part of Johnson & Johnson Family of Companies, is recruiting a Controlled Substance Specialist to be located in, Gurabo, PR.

　　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 Ortho is part of the Janssen Pharmaceutical Companies.

　　The Controlled Substance Specialist is responsible for the import – export permits handling, C3 - DEA 222 - DOH Forms generation, inventory systems transactions, API reconciliation, monthly-quarterly-yearly reporting, and export tool system execution for Controlled Substance products.

　　Assist and support CS Compliance Specialist DEA in internal and external audits / inspections and site projects related to control substances. Also, support the CS global partners interactions and is responsible to maintain accurate CS quality records, support change control documentation, assists with the new hire documentation, CS reporting, CS Employee Sensitive Report reconciliations, CS destructions, document management, ready book maintenance, license renewal, metrics, Diversion Prevention Plan (DPP) documentation, procedure modifications and DEA reporting.

　　Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

　　Key Responsibilities:

　　Responsible for the Schedule III Controlled Substances product handling and support the Schedule II and Listed Chemical products management at the site.

　　Responsible for keeping up to date on FDA/GMP/DEA regulations.

　　Contact DEA / Department of Health of PR (ASSMCA), as the need arises, to request on-site visits to assess changes in the facility/processes that impact controlled substances.

　　Responsible for timely issuance and submittal of controlled substances reports/documents to the regulatory agencies DEA / ASSMCA and to corporate group.

　　Responsible for review, evaluation and approval of SOP’s and Change Controls related to controlled substances.

　　Maintains all necessary licenses up to date e.g., DEA, ASSMCA, Department of Health, USDA, etc.

　　Support the review of NCR’s related to controlled substances products.

　　Support the Internal Audit Program to assure plant wide compliance with current GMP's guidelines, controlled substances, corporate standard operating procedures, policies, rules, and regulations.

　　Support the internal/external Corporate and/or Regulatory Agencies audits/inspections. Perform audit readiness and audit support role.

　　Complete the inspection readiness plan and report issues, risk, progress to the CS Compliance Manager.

　　Acts as a compliance representative in Site projects impacting Controlled Substance products trend activities.

　　Enforce all products are manufactured and packaged under quality systems and procedures.

　　Complies of the goals of the CSGO and Quality Organization.

　　Assist the CS Compliance Manager in the CS Program documentation requirements.

　　Managed the Export Tool, SAP (IM-WM), Trackwise, ELIMS and ARCOS System’s.

　　Qualifications

　　Education:

　　A minimum of a Bachelor’s degree with focus degree in science (Pharmacy, Chemistry, Biology or Engineering) or other related is preferred.

　　An MS/MA/MBA is preferred.

　　Experience and Skills:

　　Required:

　　A minimum of six (6) months of experience in the manufacturing regulated industry is required; previous COOP and/or internship experience will be considered.

　　Experience in the Compliance areas (Complaints, Internal Audits, Change Controls, NDA), Materials/Logistics or business excellence within the pharmaceutical industry.

　　Strong knowledge of GMP's, Compliance, internal and external regulations (FDA/DEA/MHRA), policies and procedures are required, as well as broader knowledge of all processes within the Quality area.

　　Literacy in SAP System in the inventory and warehouse management Areas. This includes the understanding of relevant transactions in the manufacturing, quality assurance, warehouse, compliance, and financial areas.

　　Inventory SAP System Experience

　　Business Excellence Background or Certification

　　DEA Regulation Expertise

　　Compliance Experience

　　Preferred:

　　Materials & Logistic Certifications (Ex. APICS)

　　Train the Trainer Training

　　Knowledge in Controlled Substances, Trackwise system, eLIMS, Metrics, Export Tools, ARCOS System, REACT System, and SAP System applications.

　　Other:

　　Excellent oral and written communication skills in English and Spanish is required.

　　Must have technical writing, problem solving, decision making, leadership, high level judgment and discernment skills, business and technical competence, ability to facilitate and influence change.

　　Computer knowledge in Microsoft Software application is required (Word, Excel, Power Point, Outlook).

　　This position may required up to a 10% of domestic travel time to support the Controlled Substance Global Organization (CSGO).

　　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 NA-US-Puerto Rico-Gurabo

　　Organization Janssen Ortho LLC (2162)

　　Relocation Eligible: No

　　Travel Yes, 10 % of the Time

　　Job Function Health Care Compliance

　　Req ID: 2306159239W