DEA Compliance Specialist
- Expired: over a month ago. Applications are no longer accepted.
Experic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalable solutions for every phase of a product's life cycle from clinical to commercial. We offer advanced pharmaceutical manufacturing, packaging, and labeling technologies that can accommodate a variety of dosing and packaging formats. We take pride in our precision capabilities, state-of-the-art filling equipment, advanced technologies, and Class A regulatory compliant cGMP facilities. Our main goal is to provide our clients personalized attention and ensure the smooth and successful completion of their pharmaceutical development programs.
We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relentless focus on delivering high quality results. If you value a collaborative work environment and are energized by the opportunity to truly make a difference, come and Experience the Experic difference. We believe in fostering a fair and respectful work environment that encourages open communication and continuous improvement. At Experic, you can experience a fulfilling career, do meaningful work, and grow professionally and personally. A successful candidate will bring their unique thinking, expertise, and approach while sharing our core values.
The successful candidate will be:
Accountable for the day-to-day site activities related to DEA controlled substances as well as ensure compliance with all federal and state regulations and requirements as they apply to controlled substances and Experic's standard operating procedures. The DEA Specialist will report to the Head of Quality and Compliance and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of Quality and Compliance.
Essential Duties and Responsibilities:
- Manage receipt, storage, dispensing, shipment and record keeping of controlled substances
- Maintain DEA Registrations for the site including those for R&D and Analytical departments and provide support during DEA audits and inspections.
- Maintain list of authorized personnel
- Preparation, maintenance, shipping and ordering of DEA 222 form.
- Coordinate controlled substance destruction with Reverse Distributor.
- Manage physical inventory counts (i.e. Biennial, Mid/Year-End).
- Manage the completion and submission of required DEA records and reports for controlled substances: ARCOS Reports, Year End Reports, Quota Submissions, Import/Export Applications, SOP's.
- Conduct periodic internal audits of manufacturing and analytical departments for continuous improvement of the CS process and ensure regulatory compliance with 21 CFR (Part 1300 - End).
- Assist in conducting Due Diligence within the Order Analysis System, company partners and customers.
- Maintain documentation to support DEA inspection-readiness (i.e., API/batch reconciliations).
- Receipt, log-in and inventory control of DEA related API's, excipients, reference standards and raw materials.
- Understands timelines and demonstrates a sense of urgency in work and in responding to colleagues.
- Proactive, good organizational and time management skills
- Follow and enforce GMP and DEA practices and applicable Standard Operating Procedures. Report any concerns immediately to the management.
- Assist with training of new and current employee on DEA responsibilities and participate in department or company projects/initiatives as requested.
- Interact with any and all other departments to resolve any issues regarding DEA materials
- Other duties may be assigned by the Site Head of Quality
Qualifications and Experience:
- Bachelor's degree in Chemistry, Pharmacy, Microbiology, or related field preferred; or equivalent combination of education and pertinent, progressive experience in pharmaceutical or other highly regulated industry.
- Minimum of four years of experience in the pharmaceutical industry with at least two years in DEA Compliance, or relevant experience in a related field.
- Knowledge of and ability to apply cGMP regulations and DEA regulations pertaining to controlled substances.
- Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
- Demonstrated interpersonal skills to develop and maintain strong working relationships with diverse individuals and work groups in a multi-disciplinary environment.
- Strong oral and written communication skills, with ability to be clear and succinct in a variety of communication settings and styles; to include reports, presentations and technical documents.
- Advanced organizational skills to complete multiple activities and projects on time and within defined scope/requirements.
- Demonstrated ability in working independently and as part of a team.
- Must be able to work in a cross-functional environment interacting with other internal departments and external vendors
- Excellent communication (oral and written) and interpersonal skills
- Knowledge of cGMPs and DEA regulations (CFR Part 1300 - End). Knowledge of processes preferred.
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