Position Title:  Associate, Operations Compliance                               

Department: Global Program Operations    

Location: Hybrid (remote within commuting distance to Stamford office)

Key Relationships:      Reports to: Senior Manager, Operations Compliance

Assignment Type: Full-time

Compensation: $46,500

Benefits:                       Work With Us | Americares

 

The Operations Compliance Associate will serve as a resource working across the Access to Medicine (A2M) Operations team to ensure we understand our compliance requirements and that our policies, processes, and procedures are identified, documented and available as needed and upon request, both external and internal. This role will support management of the portfolio of policies and procedures, business process maps, staff training and other documentation that guide and document our activities to ensure high quality, compliant operations. A primary focus of this role will be compliance with the Drug Supply Chain Security Act. It will require collaboration, both internally and externally, to support development of internal policies, processes, and procedures.

In the first 90 days, the Associate will be able to...

·         Summarize comprehension of standards regulating Americares distribution model and compliance processes

·         Support active monitoring and verification of transaction data for received pharmaceuticals in HELM inventory system

·         Assist Sr. Manager, Ops Compliance in identification of DSCSA stock issues and drive to resolution with stakeholders

 

In the first 6 months, the Associate will be able to …

·         Direct SOP maintenance and support of document owners

·         Support active monitoring and verification of transaction data for received pharmaceuticals in HELM inventory system

·         Support identification of DSCSA stock issues and drive to resolution with stakeholders

·         Support documentation of DC staff training

In the first year, the Associate should be able to accomplish:

·         Pro-active SOP maintenance and support of document owners; updating and developed detailed work instructions in coordination with DC staff; research and advising on compliance/GDP best practices

·         Policies and procedures completely updated to reflect HELM utilization

·         Independent active monitoring and verification of transaction data for received pharmaceuticals in HELM inventory system

·         Independent identification of DSCSA stock issues and drive to resolution with stakeholders

·     Independent documentation and support of DC staff training

 

·    Support documentation of quality assurance matters, root cause analysis, and corrective and preventative action

 

·         Ensure consistency between SOPs, business process charts, HELM user guides and other training documents

·         Coordinate training plans for compliance requirements and support training

·         Support the Operations Compliance Manager and Distribution Center in documentation of staff training for compliance requirements

·         Serve as point of contact for recall notifications and monitor FDA website for new recalls weekly, identifying matches to product received by Americares

·         Coordinate with Distribution Center, Strategic Partnerships and Gift-in-Kind to quarantine recalled stock and arrange disposal

·         Coordinate with Technical Unit and Global Programs to notify partners of recalled product shipped by Americares and provide disposal instructions, tracking confirmations of receipt and disposal

·         Manage Ops records retention requirements and ensure team is saving and purging documents as required

·         Generate monthly / quarterly reporting as needed by Legal/Compliance to fulfill state licensing requirements

 

 

·         You have a BA in Supply Chain or Logistics preferred. (Equivalent combination of relevant education and experience may be substituted as appropriate)

·         You have strong organizational skills with projects, processes and people

·         You have the ability to juggle many tasks and shifting priorities

·         You have excellent collaboration skills and the ability to work with a wide range of personalities with competing priorities

·         You have consistent attention to detail in understanding requirements and translating these to process needs and issue resolution

·         You have strong writing skills for SOP management

·         You are software savvy – ability to learn, use, train, and support within different applications – Microsoft Suite (including Visio). You are able to maximize the utility of different applications to minimize administrative burden

·         You have demonstrated experience as a team player, willingness to jump in and help across the team where needed, even outside of identified job requirements

·         You have additional language fluency in one of our core languages: Spanish, Tagalog, Hindi, Kiswahili, Haitian Creole (this would be a plus, but is not a requirement).

·         You have US work authorization (required)

 

·         Video interview with People and Talent (45 minutes)

·         Video interview with Senior Manager, Operations Compliance and Director, Supply Chain Management (1.5 hours)

·         Reference check and background check

·         Offer

Americares is currently authorized to support remote work employees in the following locations: Alabama, Arizona, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, and Washington.