POSITION SUMMARY:
This position is responsible for developing, implementing, coordinating and performing processes and procedures to ensure compliance with all applicable state and federal regulations including Drug Enforcement Agency, FDA, and State Board of Pharmacy. This position will manage local DSCSA compliance to include product information verification, product validation exceptions, product quarantine, and disposition. This position may also serve in a staff (advisory) capacity for the processes related to compliance within the DC, controlled substance cage and vault. This position reports directly to the Compliance Manager with oversight by the DC Manager.
ESSENTIAL FUNCTIONS
Reasonable Accommodations Statement
To accomplish this job successfully, an individual must be able to perform each essential function satisfactorily, with or without reasonable accommodation. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
Essential Functions Statements
· Conduct Pedigree Authentications on inbound orders.
· Ensure all Compliance policies are followed at all times.
· Assist in responding to audit requests.
· Assist other Compliance Specialists, Sr. Compliance Coordinator, Compliance Manager and Director of Compliance as needed.
· Review and resolve compliance exceptions.
· Contacting and assisting internal and external customers as needed via email or phone.
· Assist with special projects as required.
· Maintain Inventory accountability records for all controlled substances.
· Maintain facility licensure with all governing bodies.
· Manage secured area access, records and compliance.
· Maintain destruction process and records for controlled substances.
· Report theft and losses of product to regulatory authorities
· Other duties as required.
POSITION QUALIFICATIONS
Competency Statement(s)
· Accountability - Ability to accept responsibility and account for his/her actions.
· Analytical Skills - Ability to use thinking and reasoning to solve a problem.
· Assertiveness - Ability to act in a self-confident manner to facilitate completion of a work assignment or to defend a position or idea.
· Communication, Oral - Ability to communicate effectively with others using the spoken word.
· Decision Making - Ability to make critical decisions while following company procedures.
· Tactful - Ability to show consideration for and maintain good relations with others.
· Accuracy - Ability to perform work accurately and thoroughly.
· Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.
· Time Management Skills - Ability to organize and direct oneself in a fast paced, time sensitive environment.
· Honesty / Integrity - Ability to be truthful and be seen as credible in the workplace.
· Detail Oriented - Ability to pay attention to the minute details of a project or task.
· Organized - Possessing the trait of being organized or following a systematic method of performing a task.
SKILLS & ABILITIES:
Education: Industry knowledge preferred; Associate degree a plus
Experience: 1 -3 years of experience in Regulatory Compliance a plus
Computer Skills: Must have a strong working knowledge of the Microsoft Office Suite of products with specific knowledge of Excel, Word and Outlook. In addition, willing to work fluidly with the AS400 and the company operating software and systems to function effectively in this position.
Certifications
& Licenses: None
Other Requirements: None
PHYSICAL DEMANDS
N (Not Applicable) Activity is not applicable to this position.
O (Occasionally) Position requires this activity up to 33% of the time (0 - 2.5+ hrs/day)
F (Frequently) Position requires this activity from 33% - 66% of the time (2.5 - 5.5+ hrs/day)
C (Constantly) Position requires this activity more than 66% of the time (5.5+ hrs/day)
Physical Demands
Lift and Carry O
Stand O
Lift 10 lbs or less O
Walk O
Lift 11 – 20 lbs O
Sit F
Lift 21 – 50 lbs O
Manually Manipulate F
Reach Outward O
Push / Pull O
Climb N
Crawl N
Squat or Kneel O
Bend O
Grasp O
Speak O
Other Physical Requirements
· Vision (Near, Color, Peripheral, Depth)
· Sense of Sound - Must be able to communicate by phone with inside and outside customers.
We are a generic pharmaceutical distributor located in the Memphis area since 1987. Our company mission is to consistently deliver cost-effective generic pharmaceuticals while providing unmatched service to our pharmacy and supplier partner.
We are proud to be an Equal Opportunity Employer of Minorities, Women, Protected Veterans, and individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, color, sex, religion, age, sexual orientation, national origin, veteran status, disability, or any other classification protected by law.