Controlled Substance Compliance Specialist

Noramco is a leading specialty active pharmaceutical ingredient (API) development and manufacturing company that supports the advancement of opioid and non-opioid products in a range of therapeutic applications. Founded in 1979, the company is headquartered in Delaware and maintains operations around the world.

Specialists in controlled substance development and manufacturing, Noramco is a partner to the pharmaceutical industry:

– Delivering DEA-compliant security and production capacity, from kilos to multi-ton supply
– High-purity controlled substances from narcotic raw materials
– Formulation-friendly particle size grades and extended technical packages
– Supporting world-class supply security of controlled substances, from schedule I to schedule III

https://www.noramco.com/

GENERAL PURPOSE OF JOB

Performs weekly sample transfers to ensure accurate accountability and works with the QC and R&D labs to prepare material for destruction. Monitors sample transactions through reporting tools. Oversees third party state licensing process and handles other state licensing directly. Participates in additional CS compliance activities as necessary.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Meets weekly with QC and R&D personnel to conduct laboratory transfers and/or disposals to ensure samples that are no longer needed are processed through the area timely and efficiently.
• Investigates any discrepancies identified during the above process or during spot checks performed through Intellitrack.
• Maintains the customer and client list and updates them monthly.
• Updates tracking documentation for laboratory sample kittings and/or disposals.
• Participates in the year-end physical inventory process.
• Compiles data to support department metrics.
• Participates in the development and delivery of training for controlled substance activities.
• Serves as a primary CS Compliance contact for controlled substance laboratory activity.
• Collects and in some cases, submits required information for State Licensing Program. Liaison with third party state licensing company to ensure renewals are done on time.
• Participates in Tier II meetings.
• May participate in DEA or State inspections.

ADDITIONAL POSITION REQUIREMENTS

• May need to travel to other Noramco sites on occasion.
• Assist 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, 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
• making suggestions for improvement
• providing overtime or help with other duties as needed
• learning new skills, procedures and processes
• remaining current in skills and industry trends
• supporting co-workers

SUPERVISORY RESPONSIBILITIES

Assumes responsibilities for other members of CS Compliance when needed. May supervise a casual part-time employee or third-party contractor or a co-op student.

EDUCATION and/or EXPERIENCE

Associate's degree (A. A.) or equivalent from a two-year college or technical school and at least four to six (4-6) 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.

LANGUAGE 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.

MATHEMATICAL SKILLS

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

REASONING ABILITY

• Data driven individual.
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

• SAP experience helpful.
• Uses word processing and mathematical software programs, customizing them to meet business needs.

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 during inventories or laboratory transfers.
• May be required to lift up to 25lbs.

Noramco provides opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Job Type: Full-time

Pay: $65,000.00 - $75,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Application Question(s):

• Are you willing to undergo a background check, in accordance with local law/regulations?

Work Location: In person

Salary : $65,000 - $75,000