Title:  Associate DEA, Compliance

JOB PURPOSE

The incumbent should have the ability to guide and support all DEA regulated business activities involved in the pharmaceutical manufacturing, analysis, and distribution of controlled substances. These activities include procurement, recordkeeping, chain of custody, production, distribution, and destruction. This position should also have the ability represent the company by interfacing with government agencies.

KEY ACCOUNTABILITIES

• Regular and predictable onsite attendance and punctuality.
• Act as DEA Coordinator by monitoring and coordinating all DEA related actives at the Hikma Dayton, NJ facility.
• Train with staff and onsite activities at the Hikma Cherry Hill, NJ facility as needed.
• Work with Hikma Security to implement and maintain security control measures relating to the safekeeping of controlled substances.
• Monitor controlled substance quotas.
• Monitor chain of custody transfers throughout manufacturing and laboratory support operations.
• Ensure clear and efficient methods for maintaining Production Batch Record accountability.
• Report CSOS and ARCOS through the DEA website.
• Conduct inventories for initial, year-end, change in Pharmacist In Charge.
• Monitor and report the destruction of controlled substances.
• Work with Hikma Quality, Environmental, Health & Safety, and Logistic Teams.
• Review and develop policies and procedures relating to controlled substance compliance.
• Maintain a state of inspection readiness throughout all Controlled Substance Compliance activities.

QUALIFICATIONS

• Minimum: Bachelors’ degree or equivalent with a minimum of 3 years’ work experience or an equivalent overall level of knowledge based upon previous work experience.

EXPERIENCE

• Preferred Experience in injectable manufacturing.

SKILLS

• Must have strong interpersonal skills and the ability to communicate with all levels of management.
• Strong knowledge of DEA regulations and how they are met in a pharmaceutical manufacturing environment.
• Able to adapt to changes in priorities based upon shifting business needs.
• Proficiency in inventory management systems (ASCTrac, SAP, etc.).
• Familiar with working in a cGMP environment and compliance with FDA regulations.
• Must show strong initiative in self-development and a desire for continued growth.  Asks for help from others and utilizes all available resources to ensure progress is continuously being gained.

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms