Specialist Quality Compliance Drug Enforcement Administration (DEA)

Johnson & Johnson Innovative Medicine•Athens, GA

1d•Onsite

About The Position

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. 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.

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.

Nice To Haves

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

Responsibilities

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.
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.