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Associate, Operations Compliance

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
About Americares:
Americares is a health-focused relief and development organization that saves lives and improves health for people affected by poverty or disaster. Each year, Americares reaches 85 countries on average, including the United States, with life-changing health programs, medicine, medical supplies, and emergency aid. Americares is one of the world’s leading nonprofit providers of donated medicine and medical supplies. For more information, visit
About the position:
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.
Key Outcomes:
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


Duties and Responsibilities:

Policies & Procedures
·         Gather and catalog individual policies and procedures
·         Update policies and procedures for consistency in formatting and level of detail
·         Research regulations and standards to identify requirements and work with our team to gather, update and catalog business process maps
·         Oversee annual reviews of policy and procedure portfolio, including updates & sign-offs
·    Support documentation of quality assurance matters, root cause analysis, and corrective and preventative action
·         Support onboarding and maintenance of Electronic Data Interchange partnerships with donors
·         Verify required Transaction Data is present and accurate for all received prescription drugs; enter Transaction Data into HELM inventory system for availability to downstream trading partners
·         Monitor stock for Drug Supply Chain Security Act (DSCSA) issues and coordinate with Strategic Partnerships to resolve
·         Serve as liaison between the Distribution Center, Strategic Partnerships and Legal & Compliance (and outside counsel) to research and resolve product issues related to DSCSA
·         Provide support with audit needs requested of the Distribution Center, Logistics and GIK teams
·         Finalize SOP packet that demonstrates compliance with Wholesale Distribution requirements; lead internal audit of SOPs to ensure compliance or identify gaps
·         Support internal and external audit activities
·         Coordinate follow-up requests and needs, based on findings
·         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
Recall Management
·         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

We’d love to hear from you if…

·         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)
What you can expect:
·         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
As a global health organization, we are committed to ensuring a safe environment for our staff, partners, and visitors. All Americares staff and visitors who are on-site at any of our locations or will be traveling for work are required to be fully vaccinated (which includes a booster, when eligible) against COVID-19 unless an exemption required by law is applicable.
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.   
Americares is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, sex, sexual orientation, gender expression, pregnancy or pregnancy-related condition, age, national origin, ancestry, physical or mental disability, genetic information, marital status, veteran status, or any other characteristic protected by law.
To request a disability accommodation to participate in the job application or interview process, please contact us at