Controlled Substances Compliance (Principal Systems Data Analyst) Specialist

Mallinckrodt Pharmaceuticals Saint Louis , MO 63150

Posted 3 weeks ago

Job Title

Controlled Substances Compliance (Principal Systems Data Analyst) Specialist

Requisition

JR000014074 Controlled Substances Compliance (Principal Systems Data Analyst) Specialist (Open)

Location

St. Louis, MO (Pharma) - USA032

Additional Locations

St. Louis, MO

Job Description

The Specialist, Controlled Substances Compliance (Principal Systems Data Analyst) is responsible for continually monitoring complex issues pertaining to processes and procedures for inventory control, quota monitoring, and adherence to Title 21 of the Code of Federal Regulations related to controlled substances and International Narcotics Control Board regulations.

Essential Functions

  • Perform Daily review of Quota Consumption and related KPIs. Reconcile system transaction inaccuracies and ensure inventory levels are within DEA requirements for each drug type.

  • Monitor Bills of Material, Management of Change, and New Item Set-Up

  • Produce year-end reports for all aspects of controlled substances

  • Compile monthly, quarterly, and yearly reporting data for submission to the U.S. Drug Enforcement Administration (DEA)

  • Assemble information for quota requests in support of the Sales & Inventory Operations Planning process

  • Item Master Maintenance, transaction rule creation, and general system updates

  • Monitor and support the Microsoft Access database used to create the foregoing reports

  • Compile inventory

  • Lead Annual non-BPCS inventory count

  • Enter Quota information into BPCS

  • Support response to DEA audits

  • Submit yearly alcohol usage and modified and new formulas to Alcohol and Tobacco Tax and Trade Bureau (TTB)

Minimum Requirements

Education / Experience / Skills / Competencies:

  • Bachelor's degree

  • Pharmaceutical Manufacturing, Inventory Control and/or Data Mining skills.

  • AS400 Interface

  • ODBC, Query Ability
  • Excellent skills using Microsoft Office Applications, more specifically advance user of Excel (pivot tables, lookups, conditional formatting, and filtering). and Microsoft Access.

  • Sequel ViewPoint Experience Preferred

  • Data Mining Experience

  • Material requirements planning in manufacturing environment

  • Excellent oral and written communication skills

  • Detail-oriented

  • Ability to influence without authority

Organizational Relationship/Scope:

  • This position reports to the Sr. Manager Controlled Substances Compliance within the Legal Organization and has no direct reports.

  • Principal Systems Data Analyst

  • Controlled Substance Compliance interacts with many internal customers: Senior Management Manufacturing, Research and Development, Laboratories, Marketing, Logistics, Warehousing, Customer Service and Marketing.

Working Conditions:

  • 90% of the time will be spent in a traditional office setting, and 10% in a manufacturing or laboratory environment.

  • Must wear safety glasses and other protective items as required.

  • Sitting 75% of the day; standing or walking 25%.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.


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