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Description

Job Purpose:

The DEA Compliance Manager is responsible for ensuring the organization complies with the regulations set forth by the Drug Enforcement Administration (DEA). This role serves as the organization’s subject matter expert for controlled substances and as a power of attorney for the organization’s-controlled substance registrations with a focus on overseeing and managing the organization's policies and procedures related to controlled substances to ensure they align with federal, state, and local laws. The DEA Compliance Manager works to minimize risks of legal or regulatory violations, implements and monitors risks to compliance in the management of control substances, and conducts internal review/investigations. This role also supports the training of staff on best practices for handling, storing, and managing processes for controlled substances. The DEA Compliance Manager serves as a liaison between the organization and regulatory bodies, providing regular reporting, responding to any inquiries or audits and staying up-to-date on changes to relevant laws and regulations.

Essential Duties and Responsibilities:

Develop, revise and maintain procedures for DEA compliance and controlled substance processes (documentation, inventory, traceability, accountability).
Manage day-to-day operations to maintain DEA compliance across the organization.
Assist with compiling and preparing documentation for DEA reporting requirements (ARCOS, YERS, acquisition, quota, destruction, theft, and loss).
Assist with compiling and preparing documentation for individual U.S. State’s reporting requirements related to controlled substance transactions in order to meet licensing/registration requirements.
Maintain records for controlled substances for ease of reference and use in reporting to regulatory agencies. Secure records according to regulatory standards and requirements.
Serve as a power of attorney for the organization’s DEA registrations to execute controlled substance purchases and maintain controlled substance order forms (DEA Form 222) for Schedule I and II compounds.
Supervise and maintain controlled substance inventory, inventory management and inventory reporting.
Assist Environmental Affairs with the disposal of controlled substance waste through reverse distribution vendors to maintain compliance with applicable South Carolina and Federal regulations.
Ensure inspection readiness and participate in DEA and FDA regulatory inspections.
Investigate deviations from standard operating procedures (SOP)s related to controlled substances and recommend corrective/preventive actions.
Assess current systems and develop more efficient tracking and reconciliation tools to improve compliance.
Support the design and implementation of training for staff on DEA compliance requirements.
Report concerns and improvement opportunities to leadership.

Supplemental Functions:

Assist with additional work duties or responsibilities as needed or required.
Flexibility to work weekends and overtime, if needed or required.

Job Specifications and Qualifications:

3+ years of direct controlled substance program management, preferred.
3+ years of pharmaceutical experience, preferred.
Thorough knowledge of CFR 21 part 11, 210, 211, and 1300.
1-2 years of project management and/or coordination experience, preferred.
Experience in root cause analysis and technical writing, preferred.
Knowledge of GMP and Controlled Substance Act through education and experience.
Ability to develop and implement solutions for controlled substance noncompliance.

Knowledge & Skills:

1–3 years of experience with Microsoft Word, Excel, PowerPoint and TrackWise preferred.
Experience with DEA and FDA inspections.
Experience working with controlled substances and managing controlled substance programs.
Experience in root cause analysis and technical writing.
Strong organizational skills with the ability to manage multiple projects or assignments simultaneously.
Effective written and verbal communication skills, with the ability to collaborate across departments.
Ability to foster a collaborative work environment that values trust, teamwork, and open communication.
Self-motivated with integrity, able to work productively under pressure and meet development goals.
Strong analytical and problem-solving skills, with the ability to translate strategic objectives into actionable tasks.
Detail-oriented with a strong ability to manage resources and ensure data accuracy.

Education/Experience:

Bachelor’s degree in a scientific discipline and 3–5 years of related experience with controlled substances, or 3-5 years of experience in the pharmaceutical industry using, preferred.

Working Conditions / Physical Requirements:

This position requires bending, lifting (up to 40 lbs.), standing, sitting, and walking throughout the facility.
Work in secure locations with control substances such as the vault, lower class storage and warehouse.

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Description

Job Purpose: Secondary Packaging’s main objective is to place primary packaged products into outer packaging that provides additional protection for distribution and retail. The secondary packaging process ensures the safe, compliant, and efficient transport of the pharmaceutical products. Essential Duties and Responsibilities:

Operate the Secondary Packaging equipment and determine trends (i.e. vials per minute and pallets packaged per shift).
Responsible for changeovers and end of lot procedures.
Responsible for documenting in the MBR.
Responsible for operating and repairing minor problems with Secondary Packaging equipment.
Responsible for clearing machine jams and minor adjustments.
Perform line clearances, machine challenges, exhibits, and startup checklist.
Perform cleaning, vacuuming, and other housekeeping duties to maintain a high level of cleanliness of the Secondary Packaging lines.
Be familiar with Autoclave process.
Be familiar with Laser Guided Vehicles (LGVs) and know how to clear faults.
Monitor waste and make adjustments to product placement as needed. Be able to maintain pouch appearance accordingly.
Verify lot number and expiration dates are correct.
Ensure labeling is neat and correctly placed on all products.
Follow the instructions of the paper Master Batch Record or the Electronic Batch Record.
Read and understand all Standard Operating Procedures for the tasks you are performing.
Perform additional work duties or responsibilities as evident or required.

Supplemental Functions:

Work under the direction of the Secondary Packaging Shift Supervisor or designee.
Assure the efficient performance of all department equipment.
Assist with housekeeping as needed.
Adhere to GMPs and hold those around them accountable.

Job Specifications and Qualifications: Knowledge & Skills:

Knowledge of the Pharmaceutical or Manufacturing Industry preferred
Must be able to pass a drug screening.
Must read, write, and speak English fluently.
Specific expertise, skills, and knowledge gained through education and experience.
The ability to take strategic objectives and accept accountability to drive results through effective actions.
The ability and willingness to change direction and focus to meet shifting organizational and business demands.
The ability to effectively manage ones self, demonstrates integrity, be productive under pressure, and achieve development goals.
The ability to create new products and processes that add value to the Business by generating new ideas and applying creative and analytical approaches.
Incumbents required to wear safety glasses, hearing protection, and other non-specified protective equipment as necessary.
Salary range: based on experience.
Available to work on-call per management’s request.
Must be able to work well with others.

Education/Experience:

High school diploma or equivalency is required. 1 year of manufacturing or pharmaceutical experience preferred, but not required.

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Nephron Pharmaceuticals

Current Open Positions