DEA Compliance Specialist in Rensselaer, NY at AMRI

Date Posted: 5/22/2020

Job Snapshot

Job Description

Description
DEA Compliance Specialist in Rensselaer, NY

Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 


The DEA Compliance Specialist is responsible for review and process of all documentation related to DEA Regulated Substances to ensure compliance with AMRI’s Compliance Program and all Federal and State regulations and requirements applicable to controlled substances/listed chemicals.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.
MAJOR DUTIES AND RESPONSIBILITIES   
  • Develop and maintain all documents required to submit and track quota applications to the Drug Enforcement Agency for the site.
  • Approve access to all of the controlled substance storage locations. 
  • Prepare and maintain all documentation to support site audits by the Drug Enforcement Agency (DEA). Maintain audit readiness documentation.
  • Responsible for maintaining accurate and updated inventories for all controlled substances.
  • Perform internal audits as it relates to DEA/State Investigations, Inventory Accountability, documentation, compliance with 21 CFR 1301.71-1301.76.
  • Manage the filing, execution, review, ordering and dispensation of DEA Form 222 for the site.  This includes 222 forms for the QC Laboratory, incoming/outgoing controlled substance reference standards, incoming customer 222 forms, and any incoming controlled substances.
  • Review and revise Controlled Substance Batch records for accountability and regulatory compliance.
  • Manage and maintain renewals for all Federal DEA Registrations and State Licensure and permits 
  • Works with various agencies to ensure all licensing for the site is applicable, accurate, complete and current.
  • Prepare and submit Import/Export applications to DEA through IMEX.  Review and close-out Declarations and Permits as required. Ensure that required copies of declarations and permits are retained and filed according to 21 CFR 1300. Complete biannual and yearend inventories for controlled substances as required. 
  • Complete Quarterly and Yearend ARCOS reporting to the DEA and required state reporting.
  • Performs routine site tours to verify compliance
  • Participates in the year end physical inventory count and compiles reconciled data for electronic submission to DEA YEI.
  • Coordinate all destruction for controlled substances along with the documentation required to transfer to a reverse distributor for destruction.
  • Write and revise all site SOP’s related to controlled substances.
  • Responsible for investigating all discrepancies in weighing’s and inventories of controlled substances and listed 1 chemicals. 
  • Participate in customer and DEA Audits.
  • Participate in self-development activities and provide site DEA Compliance training. 
  • Communicate the quota requirements with Supply Chain to drive the production schedule. 
  • Perform other related duties as may be reasonably assigned in the course of business.

Qualifications
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
Required
  • Associate degree or equivalent from two year college 
  • Minimum of 2 years experience executing strict government regulations, specifically with the DEA and FDA.
  • Extensive experience with and knowledge of Microsoft Office, especially with Excel.
  • Working knowledge of MRP principles and Supply Chain. 
  • High degree of initiative with demonstrated ability to work independently and meet timelines. 
  • Demonstrated ability to communicate and coordinate effectively with other departments. 
Preferred:
  • Preferred: BA/BS Degree
Language/Communication Skills
Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills 
Ability to calculate figures and amounts such rate, ratio, percentages and fractions and ability to draw or interpret graphs. Ability to apply concepts of basic algebra and geometry.
Reasoning Ability 
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear; to reach with hands and arms, stand; walk; climb or balance; and stoop, kneel, crouch, or crawl.  The employee must occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, and ability to adjust focus.

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts.  The noise level in the work environment is moderate.
Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000. Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

Job: Supply Chain
Primary Location: US-NY-Rensselaer
Other Locations:
Organization: AMRI Rensselaer
Schedule: Full-time
Job Posting: Apr 23, 2020, 7:15:15 PM
Shift Type: First Shift

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.