Job Title

Controlled substance Compliance (Quota) Specialist

Requisition

JR000014154 Controlled substance Compliance (Quota) Specialist (Open)

Location

St. Louis, MO (Pharma) - USA032

Additional Locations

St. Louis, MO

Job Description

Responsible for continually monitoring processes and procedures primarily for inventory control of controlled substances active pharmaceutical ingredient (API) and finished dose, preparation of U.S. Drug Enforcement Administration (DEA) controlled substances quota requests and reporting of controlled substances transactions in accordance with state and federal controlled substances regulations and International Narcotics Control Board (INCB) reporting requirements. The candidate will also be expected to provide DEA regulatory guidance to internal stakeholders.

Essential FunctionsControlled Substances Quota

• Collaborate with Research & Development (R&D), Business Development, Commercial, and Supply Chain functions to determine API and quota requirements.

• Preparation and timely submission of Manufacturing Quota and Procurement Quota applications in support of existing business needs and future opportunities at the St. Louis Plant.

• Monitor quota consumption by interfacing with Manufacturing and Supply Chain functions.

• Respond to DEA inquiries promptly and accurately to ensure facilitation of the quota application process.

• Facilitate timely submission of information to DEA in support of the establishment of the national Aggregate Production Quota (APQ) as required by 21 CFR 1303.

• Liaise with Procurement and Supply Chain functions to maintain uninterrupted supply of narcotic raw materials (NRMs).

• Assembles information for quota requests in support of the sales and operations planning (S&OP) process.

Controlled Substances Accountability

• Review manufacturing/packaging records to ensure accountability of all controlled substance materials during conversion from raw materials into API or finished dose.

• Ensure all inventory is allocated to the correct DEA Registrations.

New Substances/Production Methods

• Collaborate with R&D team members at the St. Louis plant to facilitate compliance with DEA and state regulatory agencies for new substances or manufacturing processes.

• Coordinate with DEA to determine classification of new substances.

• Ensure proper National Drug Codes (NDCs) appear on all St. Louis DEA registrations as necessary.

DEA Reporting

• Investigate discrepancies and file DEA Form 106 Reports promptly and within guidelines as needed.

• Assist with completion of “Year-End Reports” required by DEA to include complete and accurate accounting summaries and supporting documentation of all controlled substances activity/inventory within the St. Louis Plant for a given year.

Minimum RequirementsEducation

• Bachelor’s degree required.

ExperienceAt least five years of experience within the pharmaceutical industry, preferably in the areas of controlled substances quota management, manufacturing, quality assurance or regulatory compliance. Experience in interpreting and implementing the regulatory requirements associated with the use of controlled substance materials during all aspects of the pharmaceutical manufacturing and distribution process.

Other Skills/CompetenciesCommunicationThe individual in this role will interact with many internal stakeholders across various functions as well as the DEA so must have the ability to communicate concisely and effectively verbally and in writing.

Attention to DetailMust be thorough and precise in accomplishing a task with concern for all aspects involved; monitor and check work or information and plans for accuracy and consistency; provide information on a timely basis and in a usable form to others who need to take action.

Escalation Process AdherenceMust understand the scope of their decision-making authority; possess ability to sort through facts and personal knowledge to determine if an issue can be managed effectively or requires escalation to someone with additional knowledge without allowing much time to lapse prior to making the decision to elevate; demonstrate ability to clearly and concisely explain issues to senior leadership and ensure appropriate handoff to the next level has occurred.

Priority Setting and Time ManagementMust appropriately manage time, organize resources efficiently, and prioritize tasks.

Process ManagementMust be adept at identifying the processes necessary to accomplish tasks; understand how to organize people and activities while separating and combining tasks into efficient workflow; have ability to track and measure progress; be able to identify opportunities for synergy and integration; simplify complex processes.

Working Conditions

• 75% of the time will be spent in a traditional office setting, and 25% 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%.

DisclaimerThe 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, visit www.mallinckrodt.com.

Mallinckrodt 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.