Quality Assurance Manager
4 weeks ago
We are seeking a highly skilled Quality Assurance Manager to join our team at National Guard Employment Network. As a key member of our Building 31 Plant QA team, you will provide Quality oversight for the GMP Receiving function, ensuring the review and release of incoming product and raw material shipments.
Key Responsibilities- Lead and direct Incoming Quality Assurance staff, including managing their performance and supporting their development.
- Provide real-time QA oversight and support for GMP Receiving operations, including the receipt and review for release of product and raw material shipments.
- Collaborate with the warehouse supply chain team to resolve quality and compliance issues identified in the operation and to support process improvements.
- Ensure that changes that could potentially impact product quality are assessed according to procedures.
- Review and approve cGMP documents and records, and alert senior management of quality, compliance, supply, and safety risks.
- Support and represent Quality during audits and inspections, and support Lean Transformation and Operational Excellence initiatives.
- Ensure Quality Management System processes are executed in accordance with established procedures.
- A Master's degree and 3 years of quality assurance experience, or a Bachelor's degree and 5 years of quality assurance experience, or an Associate's degree and 10 years of quality assurance experience, or a High school diploma/GED and 12 years of quality assurance experience.
- Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
- Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent.
- Proficient with database use, including data input, archival, and query retrieval.
- Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis/Deviation investigations.
- Experience in management or leadership roles.
- Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
In addition to a competitive salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
- Stock-based long-term incentives.
- Flexible work models, including remote and hybrid work arrangements, where possible.
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