Job Title

Specialist Controlled Substance Compliance - First Shift

Requisition

JR000014157 Specialist Controlled Substance Compliance - First Shift (Open)

Location

Hobart, NY (Pharma) - USA036

Additional Locations

Hobart, NY

Job Description

Summary

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 Functions

Controlled Substances Waste Inventoried, Documented, and Secured:

• Accumulates, organizes, and maintains physical inventory of unusable controlled substance material that is received from production, customers, carriers, outside warehouses, Quality, and Research & Development (R&D).

• Manages destruction of controlled substances with internal stakeholders by performing verification; coordinate controlled substance destruction; correspond with local Drug Enforcement Administration (DEA) office to schedule destructions and forward completed DEA Form 41s.

• Responsible for data entry into inventory control system of all waste transactions.

DEA 222 Forms and Required Records Completed On Time:

• Gathers, compiles, and transmits data for quarterly and annual ARCOS reports to DEA.

• Issues and clears DEA 222 Forms when required to meet the needs of the business.

• Reviews DEA 222 Forms for compliance with the regulations (internal process review).

• Pulls copies of requested DEA 222 Forms for DEA and Customer Service

Daily Shop Order Reconciliation Ensures Accurate Inventory:

• Reviews controlled substance manufacturing/ packaging records to ensure accountability for all controlled substance materials during conversion from raw materials into finished product.

DEA Required Records and Reports Completed on Time and Within Guidelines:

• Maintains DEA records for updates and completeness including working with Legal to ensure up-to-date state licenses.

• Receives and retains all signed packing lists from customers for the receipt of controlled substances.

• Compiles and assembles all information in support of “Year-End Report for Substances Procured” to include complete and accurate accounting summaries and supporting documentation of all controlled substance activity/inventory within the plant for a given year.

Check Weight Receipt of Controlled Substances:

• Validates the accuracy of controlled substance deliveries by performing weight checks to verify the amount received.

• Complete all necessary receiving documentation for the controlled substances.

Minimum Requirements

Education:

High School diploma or equivalent.

Experience:

At least five years’ experience within the pharmaceutical industry, preferably in the area of 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.

Other Skills/Competencies:

Communication: The 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 Detail: Must 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 Adherence: Must 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 Management: Must appropriately manage time, organize resources efficiently, and prioritize tasks.

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

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%.

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.