Compliance Managers are part of the Regulatory Affairs Department. Their role, though flexible, is to manage, support, and report the development of AvKARE private label products from inception to market, support in maintaining licenses for operation, oversee quality in repackaging, as well as to ensure compliance to the Code of Federal Regulations and all cGMP requirements as governed by the FDA, DEA, and various State Boards of Pharmacy.
Essential duties and responsibilities
- Manage and Support Drug Safety Calls & Emails concerning AvKARE Private Label Products
- Manage FDA, MedWatch Letter & DEA Communication Files
- Manage licensing requirements and Governing Body Annual Report Filings
- File Maker (database) entry for Retained Sample Inventory management
- Create New Labeling (including inserts, cartons, etc.) for AvKARE Products
- Manage cGMP SOPs books, audits and log
- Review and approve Production Batch Records and log
- ARMS Data Base entry for Batch Records
- Manage AvKARE Labeled Packaging Specifications Sheets (PSS) for Apace
- Lead or support Inspections compliance and internal audits
- Lead or support Investigations for product quality issues and documentation
- Suspicious Order Monitoring Liaison to Customer Service
- Managing Training for Regulatory Team including Manual and Log
- Temperature and Humidity Data Logger Collection
- New Product info entry to PIC
- Manage All Private Label Registrations through the creation of SPLs to FDA
- Communicate FDA Registration Notifications with Time Stamps
- PIC Maintenance & Market End Date Audits
- Input PIC Status Updates from Product Development Teams
- Track and Manage Stability Costs as well as Validation Lot Stability
- Track, review and manage vender agreements
- ARMS Data Base entry for receiving retained samples
- Quarterly, Yearly, and Biennial Inventory on Controls
- Periodic Destruction scheduling and handling of Retained Samples
- Receiving and verification of Retained Samples
- DEA Form 222 management
- Reconciliations
- Facility Management and Maintenance
Other functions and Responsibilities
- Special projects in relation to PIC data, Data base management, and SOP reviews.
- Support in physical inventory management and counts
- Ensure adherence to AvKARE quality manual and Corporate SOPs.
Required Qualifications
These are the qualifications that are necessary for someone to be considered for the position.
- High School Diploma and office administration experience required
- Knowledge and ability in the use of personal computer and software applications (i.e. Microsoft Word, Excel, Access or other databases, PowerPoint, etc…)
- Strong organizational skills and analytical skills
- Ability to exercise initiative and sound judgment and to react with discretion
- Ability to communicate effectively to patients, vendors, governing bodies, co-workers, and supervisors in various forms including by phone, email, and in person.
- Ability to establish long-range objectives and specify the strategies and actions to achieve them with willingness and execution to follow up.
- High level of attention to detail
- Experience or high ability to work in team environments.
- Ability to identify and communicate a problem to the team.
- Ability to work independently, with little supervision
- Pass a DEA and TBI background check as well as a drug screening as required
Preferred qualifications
- Background or knowledge in professional audits or services
- Background or knowledge in Quality or Compliance
Working conditions
Day shift work – Monday to Friday in Pulaski, TN Corporate office
Physical requirements
- Minimal but occasional lifting and reaching of supplies and inventory (50 lbs. or less)
- Using step ladder and various office equipment
- Cleaning of department or company areas
- Sitting for extended periods of time
Benefits:
- Competitive salary and commission structure
- Comprehensive health, dental, and retirement plans
- Ongoing professional development opportunities
- A dynamic and collaborative work environment
#WeAreHealthDelivered
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.