DEA Compliance Associate

Company: Catalent Pharma Solutions, Inc.
Location: Morrisville
Posted on: November 18, 2021

Job Description:

Job Description Position Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here Position Summary: Catalent is looking to hire a DEA Compliance Associate to join a dynamic team at our Morrisville, NC site. The DEA Compliance Associate will be responsible for providing assistance to the Manager, Security and DEA Compliance. The incumbent will also comply with 21CFR1300-end, site SOPs, and cGMP policies; work closely with other departments in the handling, documenting, and inventory of controlled substances; and assist in deterring the diversion of controlled substances. The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI, and Nasal Sprays. The Role: * Assist the Manager, Security and DEA Compliance in inventory accountability and reconciliation for controlled substances, while abiding with internal SOP's and CFR requirements; verify accurate transcription of raw data into reports * Provide support and assist various departments involved in the shipping and receiving of controlled substance samples * Assist in the preparation of DEA correspondence and informational packages * Maintain controlled substance documentation and accountability to procedures and maintain high alert to diversion and theft possibilities * Assist with maintaining site regulatory documents * Support customer and agency audits of the facility and systems for controlled substances * Ensure compliance with cGMPs and applicable Catalent SOPs throughout the facility * Audit controlled substance program routinly to ensure compliance to CFR, SOPs * Other duties as assigned The Candidate: * College Degree preferred with some experience in Security and/or DEA Compliance * 1+ years cGMP experience in controlled substance environment and pharmaceutical industry preferred * Excellent verbal and written communication skills are essential * Strong attention to detail, organized and ability to multi-task are essential for success * Demonstrated ability to independently prioritize workloads and excellent problem solving, analytical, and motivational skills * Must be team oriented and able to work well within a cross-functional team atmosphere * Fully competent in the use of common computer software - Microsoft Windows, Microsoft Word, and Microsoft Excel * May be required to sit for extended periods; specific vision requirements include reading of written documents and use of computer monitor screen frequently; individual will be required to stand for hours for audit tours Why you should join Catalent: * High potential for career growth in an ever expanding team * Exposure to a global network of partners, colleagues, and clients * Medical, dental, and vision insurance, as well as company matching 401K * 152 hours of Paid Time Off per year Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit www.catalent.com/careers to explore career opportunities. Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

Keywords: Catalent Pharma Solutions, Inc., Cary , DEA Compliance Associate, Other , Morrisville, North Carolina