Specialist Quality Compliance Drug Enforcement Administration (DEA)

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.

Job Function:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America

Job Description:

We are searching for the best talent for Specialist Quality Compliance Drug Enforcement Administration (DEA) located in Athens, GA.

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

 

Purpose:

Under the guidance of the Senior Specialist Quality Compliance, the Specialist Quality Compliance will provide technical support by interpreting federal and local Controlled Substance regulations as they apply to site processes, practices, and procedures.

Key Development Areas: This role gives the opportunity to the successful candidate to explore and strengthen leadership skills as well as networking as this opportunity reports to J&J Global Platform Controlled Substance Organization.

This role is responsible for functional cross collaboration with all J&J sites controlled substance compliance departments that handle controlled substance.

You will be responsible for:

• Compile information from various site departments to complete required US Drug Enforcement Agency (DEA) reports (ARCOS, Opiate, Import/Export, Biennial, and Year-end).

• Compile and review data to support controlled substance metrics for the site.
• ;">Compile and review data to support controlled substance metrics for the site.;">Compile and review data to support controlled substance metrics for the site.

• Support Controlled Substance Compliance regulatory, internal audits, and site Quality Management review.

• Support transportation company audits and external manufacturing audits.

• Under the guidance of the Senior Compliance Specialist, will support the site for all regulatory site inspections and communications.

• Under the Senior Compliance Specialist's guidance, collect and compile controlled substance reconciliation information quarterly. Reviews controlled substance inventory in SAP / eLIMS and reviews vault adjustments as a record of accountability of product inventory using software to reconcile all product transactions.

• Support the reporting of quota inventory consumption.

• Support quality nonconforming events that are related to CS Compliance aspects of the manufacture of controlled substances through TrackWise .

• Perform gap assessments with DEA procedures and quality systems standards/policies.

• Review DEA 222 transaction forms as needed.

• Under the guidance of the SCS, support the year-end physical count of controlled substances.

• Support the annual registration and licensing process required for the manufacturing and distribution of controlled substances.

• Perform site walk-through tours to verify DEA Regulatory Compliance.

• Deliver controlled substance compliance training for site-based employees.

• Partner with site Security and other departments to maintain a secure environment for controlled substance manufacturing.

• Successfully complete regulatory and job training requirements.

• Understands and responsibly perform duties with attention to quality, safety, and environmental matters. Items include wearing appropriate personal equipment, recognizing, reporting, and appropriately responding to hazards in the work area (spills/accidents/near misses), always maintaining proper housekeeping, and other job requirements.

• Carry out duties in compliance with all local, state, and federal regulations, including FDA, EPA, OSHA, and DEA. Follow all company and site policies and procedures.

• Make a positive contribution as demonstrated by:

• Making suggestions for improvement.
• Providing discretionary effort by extending work hours when needed.
• Having a passion to expand knowledge to make a larger contribution to the site and company.
• Staying connected to changes in controlled substance regulations and associated technologies.

 

Qualifications/Requirements:

• A minimum of an Associates or equivalent university degree is required.

• A minimum of 2 years of relevant work experience.

• Ability to read, analyze, and interpret business publications, professional journals, technical procedures, and government regulations.

• Ability to prepare reports, business correspondence, and procedures.

• Ability to present information effectively and respond to questions from managers, clients, customers, regulatory agencies, and the public.

• Ability to calculate rates, ratios, percentages, and fractions and to create or interpret bar graphs.

• Ability to apply basic algebraic and geometric concepts.

• Ability to solve practical problems involving concrete variables in situations with limited standardization.

• Ability to interpret written, verbal, diagrammatic, and schedule-based instructions.

• Proficiency with word-processing and mathematical software, including the ability to customize applications to meet business needs.

• Must have knowledge of cGMPs, quality assurance, safety, and environmental regulations as they apply to a pharmaceutical or chemical manufacturing environment.

 

Other:

• This position may require up to a 10% of domestic travel.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

 

 

 

 

Required Skills:

 

 

Preferred Skills:

Audit and Compliance Trends, Audit Management, Audit Reporting, Business Behavior, Business Writing, Communication, Compliance Management, Critical Thinking, Execution Focus, Legal Function, Legal Services, Office Administration, Process Optimization, Regulatory Environment, Report Writing, Training Administration