Controlled Substance Compliance Specialist

ESSENTIAL FUNCTIONS

• Performs routine spot checks of product receipt, storage, accountability, usage, shipment or destruction in line with 21 CFR Part 1300 to End.
• Routinely verifies on hand amounts against Intellitrack and SAP.
• Investigates and resolves any discrepancies identified.
• Participates in inventories conducted at the direction of the CS Compliance Manager to ensure all product is captured and no discrepancies exist.
• Calculates material conversions and totals for reconciliation and reporting purposes.
• Tracks state licensing expiration dates and assists in the completion of license renewals.
• Maintains documentation needed for license renewals in an up-to-date manner.
• Requests completion of forms, signatures or other documents from others to support license renewal.
• Keeps track of, converts and totals material awaiting destruction for submission to third-party destruction vendor using Excel or other means.
• Routinely checks storage areas to ensure destructions are occurring on a regular basis.
• Maintains the customer and client list (along with DEA Registration numbers and expiration dates) and updates them monthly.
• Assists in the development and delivery of training for controlled substance activities.
• May participate in DEA or State inspections as a scribe or runner.
• May need to travel to seminars or meetings once or twice per year.
• Assists other departments in understanding and complying with DEA regulations.

POSITION QUALIFICATIONS

• Maintain a high degree of confidentiality in handling certain tasks.
• Assumes responsibility for the Manager of CS Compliance for critical tasks when he/she requests.
• Must be determined and strongly committed to resolving any discrepancies identified.
• Must be assertive when necessary to bring a problem to resolution.

EDUCATION/EXPERIENCE

• Associate's degree (A. A.) or equivalent from a two-year college or technical school and at least one to three (1-3) years of controlled substance compliance related experience; or equivalent combination of education and experience.
• Math or Science related BA/BS Degree plus two to four (2-4) years related experience preferred.

SKILLS

• Read, analyze, and interpret general business emails, periodicals, websites, professional journals, technical procedures, or governmental regulations.
• Write professional emails, detailed reports, business correspondence, and procedure manuals.
• Effectively present information and respond to questions from groups of managers, clients, customers, regulatory agencies and the general public.

PHYSICAL DEMANDS

• While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle, or feel; and talk or hear.
• Specific vision abilities required by this job include color vision.
• May require standing for longer periods of time, especially during inventories or spot checks.
• May be required to lift up to 25lbs.

COMPANY OVERVIEW

Halo Pharmaceutical is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. Halo has long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada. Our family of companies offers complete CDMO services including custom synthesis of intermediates, reference standards, drug substances and drug product manufacturing. Halo Pharma is part of Noramco. We are stronger together!