Controlled Substance Specialist

Johnson & Johnson•Gurabo, PR

39d

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Controlled Substance Specialist to be located in Gurabo, PR. The Controlled Substance Specialist is responsible for managing the Controlled Substance program to ensure compliance with current Good Manufacturing Practice (GMP) guidelines, as well as corporate standard operating procedures, policies, rules, and regulations. Additionally, supports internal and external audits and inspections. Also assist with site projects involving controlled substances.

Requirements

Bachelor’s degree in science (Pharmacy, Chemistry, Biology or Engineering) is required.
A minimum of 1 year of related working experience in the Compliance areas (Complaints, Internal Audits, Change Controls, NDA) 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.
Excellent oral and written communication skills in both English and Spanish, including technical writing.
Computer knowledge in Microsoft Software applications, including Word, Excel PowerPoint, Outlook.
This position may require a 10% domestic and/or international travel.
This position may require availability to work the 1st and/or 2nd shifts, including irregular (non-standard) shifts and/or weekends based on business needs.

Nice To Haves

MS/MA/MBA is preferred.
Coop experience is preferred.
Knowledge of COMET Quality System and SAP applications is preferred.

Responsibilities

Responsible for the Schedule II & III Controlled Substances Program at the site.
Responsible for staying updated on FDA/GMP/DEA regulations.
Coordinate with DEA/ASSMCA for on-site visits to assess facility/process changes affecting controlled substances.
Ensure timely issuance and submission of controlled substances reports/documents to regulatory agencies DEA/ASSMCA and corporate group.
Review, evaluate, and approve SOPs and Change Controls related to controlled substances.
Maintain up-to-date licenses such as DEA, ASSMCA, Department of Health, USDA, etc.
Support the review and approval of NCRs for controlled substances products.
Assist in the Internal Audit Program to ensure compliance with GMP guidelines, controlled substances, corporate SOPs, policies, rules, and regulations.
Support internal/external audits/inspections by Corporate and/or Regulatory Agencies.
Provide audit readiness and support.
Maintain NDA Submissions-related documentation up to date.
Act as a compliance representative in plant-wide project teams and New Products activities, particularly those related to controlled substances.
Enforce manufacturing and packaging of all products under quality systems and procedures.
Provide regulatory/compliance guidance and leadership to support company processes.
Achieve goals set by the quality team and overall business and process goals.
Adhere to the principles of conduct expressed in our Company Credo and policies.
Comply with Safety and Environmental procedures in all areas.
Prepare presentations, reports, memos and procedures.