Quality Assurance Manager
1 month ago
We are seeking a highly skilled Quality Assurance Manager to join our team at AmerisourceBergen. As a key member of our QA team, you will be responsible for ensuring that all Quality Assurance release activities associated with 3PL operations are completed in compliance with the GMPs and in accordance with contractual obligations.
Key Responsibilities- Manage a team of QA Release Specialists and Associates, assigning day-to-day activities and providing regular direction, mentoring, and coaching to the team.
- Develop effective relationships with Operations Management to ensure that the Milton Warehouse and Innomar DCs are maintained in a state of GMP compliance.
- Actively contribute to the development, maintenance, and improvement of the Innomar GMP Quality Systems.
- Host client audits, prepare formal responses, and provide support during regulatory inspections and corporate audits.
- Execute the internal audit program and communicate adverse trends to senior QA management.
- Support the Senior Manager, QA GMP with management of deviations, root cause analysis, and CAPA implementation.
- Prepare quarterly trend reports for key quality indicators and present these trends to Management.
- Support the Senior Manager, QA GMP for Product Recalls, including customer notification, coordination of customer returns, and maintaining documentation.
- Ensure Mock Recalls are run annually to meet GMP requirements for Drugs, NHPs, and medical devices within all inventory management systems utilized at Innomar.
- Administer the vendor management program, including the review, evaluation, and approval of service providers.
- Support the facility and equipment qualification programs, including temperature mapping of the warehouse, refrigerators, and freezers, execution of lane studies, and validation of pack-outs.
- Provide leadership and direction to the QA team in the absence of both Senior Manager, QA GMP.
- Work with the rest of the QA management team to develop/revise and implement QA policies and procedures as required.
- Understand and apply company Confidentiality and Privacy Agreements.
- Travel up to 20% of the time.
- Perform other duties and tasks assigned by Senior QA Management.
- Bachelor's of Science degree in a pharmaceutical or healthcare-related field (e.g., chemistry, microbiology, pharmacy, and pharmacology).
- Minimum of 6 years' experience in Quality Assurance.
- Experience in conducting vendor audits.
- Experience hosting/co-hosting client audits is considered an asset.
- Experience working in an Operations/Warehouse environment is considered an asset.
We offer a competitive total rewards compensation package, including a comprehensive benefits program, tuition reimbursement, employee referral programs, and opportunities for career advancement.
Equal Employment OpportunityAmerisourceBergen 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.
COVID-19 Vaccine PolicyAmerisourceBergen requires all Canadian team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a qualifying medical condition or sincerely held religious belief, you will be required to follow AmerisourceBergen's policy and process to apply for an exemption/accommodation.
Accessibility PolicyAmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment, and hiring processes and during employment.
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