QA - Quality Control
With guidance and support of the senior program managers, the program quality control specialist (PQCSS) conducts quality control verifications for program related services to ensure compliance with existing Standard Operating Procedures (SOPs) for Patient Assistance Programs (PAPs), Adverse Event Reporting and other internal program related SOPs. The PQCS is responsible for maintaining records of quality controls verifications, issues and follows through on CAPAs based on findings.
Additionally the PQCS associate will work closely with the program management, the program personnel and other departments such as Health Outcome, Nursing and Pharmacy services and the Quality Assurance Department to ensure client contractual agreements and AmerisourceBergen Specialty Canada's standards are followed. The PQCS associate will report to the senior program manager or the program manager.
PRIMARY DUTIES AND RESPONSIBILITIES:
1. Conduct quality control verifications of program related activities/services based on PQC SOPs; 2. Ensure that all policies and SOPs are strictly followed and adhered to; 3. Document quality control observations in approved report templates; 4. Ensure quality control records are appropriately maintained, archived and easily retrievable upon request ; 5. Provide quality controls to resolve observations within predetermined timelines; 6. Escalate quality control critical or major issues, and work with the affected departmental management on additional investigations as required. Escalate to senior management as necessary; 7. Maintain and report appropriate metrics, including, but not limited to quality control reviews to program and senior management; 8. Collaborate in the creation and implementation of corrective action plan, as required; 9. Actively collaborate with the program team and senior management to achieve customer requirements. 10. As required, prepare for and participate in external audits; 11. Implement and/or support continual process improvement related to specific Program and/or internal AmerisourceBergen Canada processes as assigned; 12. Participate in meetings with Programs and other supporting departments; 13. Support applicable training as assigned; 14. Understand and apply AmerisourceBergen Canada's Confidentiality and Privacy Agreements. 15. The PQCS associate will also be assigned other duties and tasks as required from time to time.
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
1. Bachelor of Science or equivalent in business or scientific field is preferred; 2. Normally requires a minimum of four (4) years related and progressively responsible experience in a similar position; 3. Minimum of 3 years experience in quality control and/or quality assurance roles, with preference to health care, pharmaceutical or CRO industry; 4. Possession of quality professional certification from an established organization is an asset 5. Familiarity with documentation tools
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
1. Demonstration of sound judgment and critical thinking skills are essential; 2. Excellent organizational skills; 3. Extreme attention to detail and accuracy; 4. Strong analytical, proactive problem-solving and conceptual skills; 5. Strong knowledge of relevant technology, tools and software; 6. Demonstrate high adaptability and flexibility; 7. Effective oral and written communication skills. 8. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail; 9. Excellent teamwork and interpersonal skills; 10. Excellent relationship building skills; 11. Ability to perform several tasks simultaneously and independently and to prioritize work load and consistently meet deadlines; 12. Bilingualism, French/English is required.