Vault Cage Monitor

Manufacturing & Packaging Chestnut Ridge, New York


Description

 

Job Summary - a concise overview of the job

Position is responsible for supervising the day-to-day storage, security and accountability of large quantities of controlled substance material, located in one of several company vaults or cages. Individual maintains an accurate accounting of all controlled substances located in the vault and/or cage.  He/she processes vault or cage deposits and withdrawals and supervises all activities occurring within the confines of these storage areas, assuring that no opportunities for theft or diversion exist.

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

 

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

 

§  Processing vault or cage deposits and withdrawals - deposits and withdrawals include but are not limited to, deposits of controlled raw material from Receiving; issuance of active ingredients or raw material for weighing; release or return of in-process or in-process material for Manufacturing (Blending, Compounding or Compression); issuance of bulk or in-process material to Packaging and preparation of product for shipment to Distribution or to Memphis for temporary storage. 

During these transactions, the individual:

§  Assures deposited quantities are accurate through label review and/or actual weighing of controlled material.

§  Completes the required documentation for each entry or withdrawal, to include at a minimum:

§  The date; net, tare and gross weights (or in the case of small tablet or capsule quantities, samples or finished goods, the bottle or tablet count); the full product name, strength and form (i.e. tablets, granulation, etc.); the individuals’ names who are receiving or depositing the material; the lot number and the National Drug Code (NDC). 

§  Signs off on each deposit or withdrawal to document their review and agreement with the information noted.

§  Reconciles drum weigh tickets with controlled substance logbooks.

 

 

§  Assures all individuals entering the vault or cage sign the Restricted Access Logbook.  Supervises these individuals by providing surveillance in a manner that assures the individual(s) are in sight at all times per the DEA regulations.  This includes but is not limited to, personnel from Manufacturing, Packaging, QA/QC or R&D.

§  Responsible for knowing at any given time, the quantity of material on-hand in the vault and/or cage (this may not be possible at present but is the goal once computers are added to the vault/cage areas).

 

 

§  Provides for adequate segregation of controlled product by DEA registration (i.e. Importer Registration versus Manufacturing Registration) and by QC status (i.e. rejected/hold/approved).

§  Maintains an accurate, posted list of all individuals with access to the cage or vault at the entrance to both.  Is responsible for immediately reporting any change in personnel (employee resigns, is terminated or moves to another department) to the Director, Security and Director, DEA Compliance.  Combinations and keys must be changed when employees with access are removed.

§  Immediately reports any instance of structural damage to the storage area doors, walls, floor or ceiling and any malfunction or damage to security equipment in the area, to the Director, Security and Director, DEA Compliance.

§  Performs routine inspections of previous shifts’ logbooks to provide a second check of vault/cage documentation.

§  Performs cycle counts on a daily basis to assure that any theft or loss is immediately detected and reported to the Director, DEA Compliance and Director, Security.

§  Controls and issues numbered seals in expected quantities to appropriate personnel.  Questions the need for quantities above that expected and maintains the In-Transit Control Lock Tracking Logbook to record issuance.

§  Provides data from controlled substance logbooks to Manufacturing personnel as needed for BPR (Batch Process Record) calculations.

§  Creates updates or provides input to standard operating procedures that govern vault and cage operations.  Works with other applicable departments to assure procedures meet both the DEA and business requirements.

§  Tracks and prepares material for destruction and prepares appropriate documentation to assure inventory records are complete and accurate.  This includes internal forms, DEA 41 Forms or Excel spreadsheets as appropriate.

§  During DEA inspections, assists with pulling or moving pallets to assure an adequate inventory is taken.  Acts as subject matter expert regarding vault/cage transaction history, procedures and inventory.

§  Interacts with both internal and external customers in a courteous, professional and knowledgeable manner.

§  Provides mentoring, training or guidance in a positive fashion to individuals within or outside of their department that may be less experienced in DEA requirements.

§  Must attend internal or external DEA, cGMP and Safety training on a yearly basis.

 

Total

100%

 

 

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  Two year degree; will accept a two year combination of education and experience for the right candidate.

§  Prior experience as a Controlled Substance Coordinator

§  Must be a permanent employee with at least two years of employment at the level of meets or exceeds expectations.


Knowledge

Proficiency in a body of information required for the job    

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Knowledgeable of DEA regulations and/or security requirements for controlled products

§  Knowledgeable of cGMP, Safety and Environmental requirements related to our products

§  Knowledgeable of manufacturing, warehouse or packaging process.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

§  Extremely high level of honesty, integrity and trustworthiness - as supported by past actions

§  Extremely detail-oriented

§  High level of accuracy in current work

§  Mathematical aptitude

§  Questions activities, quantities or procedures that may be out of the norm

§  Confident and assertive; but not aggressive or confrontational

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§   

 

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.