DEA/Security Activities Associate

Research & Development Seymour, Indiana


Description

Job Summary – a concise overview of the job

 

This position is responsible for implementing policies and procedures to ensure compliance with DEA and security requirements.  This includes but is not limited to inventory, production compliance, record keeping, company assets and coordination with DEA agents.  This position assists the Senior Manager of Security / DEA Activities in every aspect of the regulatory and daily processes at Lannett Company Inc. 

 

 

 

 

 

 

 

 

 

 

Scope of Job -- size of organization, P&L responsibility, budget responsibility

 

Wholly supports 6 LCI DEA Registrations at the Seymour facility to maintain compliance with CFR 21 Part 1300 to End.  This includes but is not limited to the manufacturing, distribution, analytical testing, research and import/export of controlled substances.  Alternate point of contact for all electronic reporting SAP, ARCOS, CSOS and YERS at the Seymour location.

 

 

 

Key Accountabilities – essential duties/responsibilities

Accountability

Responsibilities

% of Time

DEA

  • Performs as the company’s backup support liaison to the DEA on a daily basis and during on-site audit investigations.
  • Executables include but are not limited to DEA Form 41, Form 106, ARCOS, CSOS, YERS and Quota
  • Assist Senior Manager Security / DEA Activities with the DEA compliance issues relating to reporting requirements or other miscellaneous requests. 
  • Submits reports to the DEA and works with the administration to resolve questions and concerns.

50%

In-House

  • Tracking of in-house material transfers through the use of forms, SAP and perpetual inventory systems.
  • Compiling data for all controlled substance shipments to ensure accuracy in inventory.  This accounts for acquisitions, dispositions and destruction.
  • Performs Monthly and Quarterly reporting required by DEA.
  • Accountable for controlled substance transfers and inventory of CI – CV and List I chemicals throughout the manufacturing process.

 

25%

Security

  • Assist in maintaining security measures in the Seymour location.
  • Assist in implementing and monitoring of the overall performance of the comprehensive security program.

25%

Total Accountabilities

 

100%

 

Required

Preferred

   High School Diploma / GED

    High School Diploma / GED

X    Associate’s Degree

    Associate’s Degree

    Bachelor’s Degree

X    Bachelor’s Degree

    Master’s Degree or        Ph.D.

    Master’s Degree or        Ph.D.

    Other

    Other

 

Qualifications

Education and Experience:

Experience

(Industry and Years)

Work experience (type of industry and years of experience) and certifications required for the job

  • Bachelor’s degree preferred or Associates Degree with relevant work experience. 
  • 3 –5 years in a pharmaceutical environment
  • Knowledge of DEA requirements 21 CFR Part 1300

Specific Skills

List any additional specific skills and knowledge necessary to meet the objectives of the position; including any specialized software or equipment regularly utilized in the performance of the job, analytical skills, management or leadership skills, etc.

  • Demonstrated ability to prioritize, manage and schedule in a high volume environment to meet project and department objectives while maintaining quality goals. 
  • Demonstrated ability to work independently with minimal daily oversight.
  • Strong observational skills and attention to detail is required.
  • Must have proficient computer skills.  Microsoft Word, Microsoft Excel and SAP experience preferred.
  • Must have excellent interpersonal skills, be highly motivated, well organized and be able to develop alternative solutions to complex issues.
  • Audit experience preferred.
  • Actively promotes and personally observes safety and security procedures, and uses equipment and material properly.

Physical Requirements

List the details of the environment within/under which work is performed and physical requirements for this position, e.g., lift 50 pounds, walk across plant/warehouse, business travel (% of time).

  • Must be able to lift 25 pounds.

 

 

Scope of Decision-Making:  (Check only one box to indicate the applicable level of decision-making responsibility required for this position, without any procedures/instructions to follow.)

    Decisions require little judgment. Understand and follow basic/routine instructions and use basic/routine equipment involving few decisions.  Duties are extremely standardized and performed under direction supervision or review.

    Decisions require some judgment.  Perform repetitive or routine duties working from detailed instructions and under standard procedures. Requires making minor decisions.

X    Decisions require basic/routine analytical judgment.  Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures.  Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.

    Decisions require complex analytical judgment.  Plan and perform a wide variety of duties requiring general knowledge of company policies and procedures applicable within area of responsibilities, and including their application to cases not routinely covered.  Requires considerable judgment to work independently toward general results, devise methods, modify or adapt standard procedures to meet different conditions, make decisions based on precedent and company policies.

Level of Supervision Provided:  (Check only one box to indicate the applicable level of supervision for which this position is responsible.)

X     Individual contributor, not responsible for the work of others.

    Project direction of other employees performing the same or directly related work.

   Project direction of other employees performing the same or directly related work, including assigning, reviewing, checking work, eliminating ordinary supervisory/management positions.

    Direct supervision responsibility, including performance assessments, of 1 – 10 employees.

    Direct supervision responsibility, including performance assessments, of more than 10 employees.

 

Internal/External Contacts:  (Check only one box to indicate the applicable level of internal and/or external contacts required for this position.)

    Primarily within department or immediate work unit:  Requires contacts within the department or functional area on routine matters, or contacts with other departments.  Occasionally contacts individuals outside the organization.  Contacts are primarily for the purpose of supplying or seeking information.

 X   Regular inside and outside the organization:  Requires regular contact with subordinates and/or other departments, with occasional contacts with individuals outside the organization.  Also includes jobs with regular customer/client contacts.

    Regular inside and outside:  Requires contacts to carry out company policy and programs.  Improper handling will have considerable effect on operating results. Must often deal with persons of substantially higher rank on matters requiring explanation, persuasion and obtaining approvals.