- 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)
- 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
- 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.
- 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%.
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Controlled Substances Compliance - St Louis, United States - Mallinckrodt Pharmaceuticals
Description
Job TitleControlled Substances Compliance (Principal Systems Data Analyst) Specialist
Requisition
JR 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 FunctionsEducation / Experience / Skills / Competencies:
Organizational Relationship/Scope:
Working Conditions:
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.
Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products.Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs.
The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities.
The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visitMallinckrodt Pharmaceuticals ("the Company") maintains a continuing policy of non-discrimination in employment.
The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law.
Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities.
This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e.
Open Payments) and certain state laws.
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