Controlled Substance Compliance Specialist

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. 

Provides ongoing assistance to the Manager, Controlled Substance Compliance in ensuring compliance with Drug Enforcement Administration (DEA) regulations throughout the site. Cross trains in some critical activities to provide backup coverage when the Controlled Substance Compliance Manager is not available. This role is 100% on site in Whippany, NJ.

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. Working with the affected department and the CS Manager, 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 with keeping Standard Operating Procedures (SOP) up to date at all times and drafting new SOPs as needed.
• Provides hands-on assistance to other departments when necessary and requested by the CS Manager to ensure the site’s overall compliance. 
• Helps 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.
• Successfully completes regulatory and job training requirements.
• Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include wearing appropriate personal equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, properly labeling and storing chemicals and controlled substances, plus all other relevant job requirements.
• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company policies and procedures.
• Makes a positive contribution as demonstrated by:
  • strong attention to detail 
  • providing overtime or help with other duties as needed
  • learning of new skills, procedures and processes
  • remaining current in skills and industry trends
  • supporting co-workers

Must 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.

• 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. 

MATHEMATICAL SKILLS 

• Calculate figures and amounts such as percentages, decimals and fractions and interpret graphs. 
• High degree of experience and accuracy with Excel or other mathematical based software.
• Experience with SAP strongly suggested.
• Intellitrack or other LIMS experience would be helpful

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.
   

Halo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background.

Halo is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.