Job description
Are you looking to make a difference in a patient’s life? At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference. As an organization, we are united in our responsibility to create healthier futures. Join us and Apply today!
What you will be doing
The Manager, Quality and Regulatory Assurance is responsible for overseeing, monitoring and coordinating all aspects of the MWI Animal Health distribution center’s regulatory compliance efforts and procedures, including DEA, OSHA, PDMA and FDA. This position is assigned specific responsibility for ensuring continual and proper compliance with all divisional, corporate and government regulatory requirements in order to reduce exposure to potential fines and citations. This position is categorized as compliance critical and, as such, requires and is assigned specific responsibility for ensuring continual and proper compliance with all division, corporate and regulatory requirements.
- This is an onsite non-remote role.
Primary Responsibilities:
1. Monitors and verifies all Distribution Center (DC) state, federal licensure and DEA Registrations as required.
2. Monitors all applicable State & Federal regulations to ensure compliance.
3. Acts as liaison between DC and all state & federal regulatory agencies.
4. Manages and/or assists with all state, federal & regulatory inspections and information requests.
5. Conducts semi-annual CSRA Self Audits.
6. Manages and ensures all security systems, including access card, key control, CCTV and alarm system are maintained; oversees corporate policy regarding access control and security requirements with emphasis on the cage and vault areas.
7. Manages the DC locker program to ensure corporate policy is adhered to.
8. Manages and maintains all DC Power of Attorney documentation for all signers of Schedule 2 order forms;
9. Reviews and maintains Schedule 2 (DEA Form 222s) to ensure compliance of vendor purchases; manages customer back-order files and provides monthly submissions to DEA
10. Monitors the ABC Order Monitoring Program (OMP) at the DC level to ensure DC compliance with all corporate requirements.
11. Monitors all requirements related to servicing of Narcotic Treatment Programs including regular review of applicable CSRA forms and associated manifests.
12. Reviews and verifies that all controlled substance and listed chemical inventories (daily counts, monthly & biennial) are completed and maintained as per corporate policy.
13. Ensures that all variances identified during controlled substance or listed chemical cycle and counts and/or inventories are investigated and all necessary corrections are initiated per corporate policy
14. Process all required ARCOS corrections as per corporate policy.
15. Maintains and manages notification and submittal of all correspondence to state and federal agencies regarding losses of Rx, Controlled Substance and/or Listed Chemical product as per corporate policy.
16. Conducts periodic inventory accountability audits to ensure complete and accurate records are maintained for all controlled substance transactions in the DC, per ABC retention policy.
17. Manages & oversees all aspects of the Health & Safety Program and conducts quarterly review of all OSHA 300 Logs; Conducts all H&SP training, manages all health & safety teams, coordinate safety motivational programs, schedules and facilitates all H&SP Advisory Committee meetings, and manages all evacuation/non-evacuation drills.
18. Responsible for heightening the awareness of security issues and bringing potential diversion activities and security breaches to the attention of CSRA; identifies areas of vulnerability and propose reconciliation procedures; takes prompt correction action when unsafe acts or conditions are observed.
19. Performs related duties as assigned.
2. Monitors all applicable State & Federal regulations to ensure compliance.
3. Acts as liaison between DC and all state & federal regulatory agencies.
4. Manages and/or assists with all state, federal & regulatory inspections and information requests.
5. Conducts semi-annual CSRA Self Audits.
6. Manages and ensures all security systems, including access card, key control, CCTV and alarm system are maintained; oversees corporate policy regarding access control and security requirements with emphasis on the cage and vault areas.
7. Manages the DC locker program to ensure corporate policy is adhered to.
8. Manages and maintains all DC Power of Attorney documentation for all signers of Schedule 2 order forms;
9. Reviews and maintains Schedule 2 (DEA Form 222s) to ensure compliance of vendor purchases; manages customer back-order files and provides monthly submissions to DEA
10. Monitors the ABC Order Monitoring Program (OMP) at the DC level to ensure DC compliance with all corporate requirements.
11. Monitors all requirements related to servicing of Narcotic Treatment Programs including regular review of applicable CSRA forms and associated manifests.
12. Reviews and verifies that all controlled substance and listed chemical inventories (daily counts, monthly & biennial) are completed and maintained as per corporate policy.
13. Ensures that all variances identified during controlled substance or listed chemical cycle and counts and/or inventories are investigated and all necessary corrections are initiated per corporate policy
14. Process all required ARCOS corrections as per corporate policy.
15. Maintains and manages notification and submittal of all correspondence to state and federal agencies regarding losses of Rx, Controlled Substance and/or Listed Chemical product as per corporate policy.
16. Conducts periodic inventory accountability audits to ensure complete and accurate records are maintained for all controlled substance transactions in the DC, per ABC retention policy.
17. Manages & oversees all aspects of the Health & Safety Program and conducts quarterly review of all OSHA 300 Logs; Conducts all H&SP training, manages all health & safety teams, coordinate safety motivational programs, schedules and facilitates all H&SP Advisory Committee meetings, and manages all evacuation/non-evacuation drills.
18. Responsible for heightening the awareness of security issues and bringing potential diversion activities and security breaches to the attention of CSRA; identifies areas of vulnerability and propose reconciliation procedures; takes prompt correction action when unsafe acts or conditions are observed.
19. Performs related duties as assigned.
What your background should look like
Requires broad training in fields such as business administration, accountancy, sales, marketing, computer sciences or similar vocations generally obtained through completion of a four year bachelor’s degree program or equivalent combination of experience and education; normally requires a minimum of four (4) years directly related and progressively responsible experience.
1. Good understanding of legal and regulatory compliance regulations
2. Knowledge of Federal, State and local regulatory agencies
3. Detailed understanding of all warehouse practices and procedures
4. Ability to communicate effectively both orally and in writing
5. Effective presentation and training skills
6. Strong interpersonal skills
7. Strong leadership skills
8. Effective negotiation skills
9. Strong organizational skills; attention to detail
10. Good analytical skills; self-motivating
11. Ability to follow and interpret government regulatory requirements and changes
12. Ability to implement processes resulting in satisfactory audit practices
13. Strong decision making skills
14. Excellent problem solving skills; ability to resolve issues effectively and efficiently
15. Working knowledge of Microsoft Office Suite
2. Knowledge of Federal, State and local regulatory agencies
3. Detailed understanding of all warehouse practices and procedures
4. Ability to communicate effectively both orally and in writing
5. Effective presentation and training skills
6. Strong interpersonal skills
7. Strong leadership skills
8. Effective negotiation skills
9. Strong organizational skills; attention to detail
10. Good analytical skills; self-motivating
11. Ability to follow and interpret government regulatory requirements and changes
12. Ability to implement processes resulting in satisfactory audit practices
13. Strong decision making skills
14. Excellent problem solving skills; ability to resolve issues effectively and efficiently
15. Working knowledge of Microsoft Office Suite
What AmerisourceBergen offers
We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.
Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.
Schedule
Full time
Affiliated Companies
Affiliated Companies: AmerisourceBergen Services Corporation
Equal Employment Opportunity
AmerisourceBergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
colinoncars.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, colinoncars.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, colinoncars.com is the ideal place to find your next job.