Manager, DEA Compliance

Company: Cambrex
Location: Charles City
Posted on: March 20, 2023

Job Description:

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes medical, dental, vision, Life, LTD, retirement savings and more! Can we make this broader language, so it fits in all markets, e.g., that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview Position is responsible for ensuring that Cambrex Charles City, Inc. (CCC) is compliant with Drug Enforcement Administration (DEA) regulations and requirements. This individual monitors day-to-day operations related to controlled substances (CS) and manages the overall site CS program. This individual will interact with regulators and customers on CS related matters, and represent the company during third party audits and inspections. Responsibilities Responsible for monitoring and maintaining compliance with DEA regulations pertaining to shipping, manufacturing, analytical and research activities associated with controlled substances and listed chemicals. Maintain all related registrations with DEA and other agencies as needed. Maintain State licensure program. Complete associated reporting requirements. Complete and file ARCOS quarterly and year end reports. Maintain CS and listed chemical files including those pertaining to shipping, receiving, 222 forms, ARCOS reports and correspondence with the DEA or appropriate State agencies. Interface with DEA as needed, including written, oral and face to face interactions. Maintain records and correspondence relating to the destruction of CS. Maintain complete and accurate records pertaining to CS related operations and lab handling. Complete, reconcile and report all CS and listed chemical inventories. Assist all departments with CS related issues. Prepare and conduct employee training on DEA requirements and related site SOP's as needed. Author and maintain site SOP's and policies relating to CS operations and handling. Work with Sales/Marketing and customers to obtain appropriate volume requests for CS quota. Liaise with customers and represent the site during audits and inspections related to CS handling. Participate on project teams for new project onboarding; liaise with DEA as needed to facilitate CS-related issues such as registration updates, quota needs, controlled status determinations, etc. Oversee shipment of CS, including import, export and management of suspicious order monitoring program. Oversee security programs related to CS handling and mfg. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned. Education, Experience & Licensing Requirements 4 year degree, preferably in Chemistry, Biochemistry, Biology or Engineering. 5 or more years of experience in administering controlled substances or products with strict regulatory guidelines. Strong working knowledge of DEA regulatory requirements highly beneficial. Sound written and oral communication skills. Experience in communication with government agencies. Training experience beneficial. Strong working knowledge of a computer applications within a Windows-based environment required. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program.' Relocation assistance will be offered for this position.

Keywords: Cambrex, Rochester , Manager, DEA Compliance, Executive , Charles City, Minnesota