Senior Associate Quality Assurance - Quality Systems-Holly Springs, NC

Job DescriptionATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Sr Associate QA - Quality SystemsWhat you will doLet's do this! Let's change the world!The Quality Management System (QMS) is the foundation that enables us to deliver on our mission to serve patients. In this role you will serve as Sr. Associate I in Quality Assurance responsible for specific systems within the QMS at ANC. This position provides the opportunity to work directly with cross functional stakeholders, the Amgen global network, and the site to implement, maintain, and improve critical systems.Drive implementation of Quality Systems in compliance to Amgen Standards and Regulatory expectationsTrack implementation progress and monitor systems performance and report status forumsAlert management of quality, compliance, and safety risksAuthor / review / approve quality documents, such as SOPs, reports, and training materials.Support Lean Transformation and Operational Excellence initiativesPerform training impact assessments for controlled documentsServe as site SME for Document Management and Learning and Performance, liaising with the global network for alignment and best-practice sharing and ensuring effectiveness, efficiency, and compliance at siteParticipate in inspection preparation activitiesProvides quality oversight for quality records including deviations / CAPAs, assuring adherence to procedural requirements and confirming assessments and evaluations of stakeholders are complete and accurateMaintain and support the training programSupport continuous improvement initiatives by identifying training-related solutions to reduce deviations and enhance complianceAdditional Qualifications / ResponsibilitiesWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a flexible, and driven individual with these qualifications.Basic Qualifications : High school / GED 4 years Quality Operations or Laboratory work experience ORAssociate's 2 years Quality Operations or Laboratory work experience ORBachelor's 6 months Quality Operations or Laboratory work experienceMaster'sPreferred Qualifications : Educational background in a science fieldStrong cGMP and GDP behaviorsExperience in biotechnology or pharmaceutical plant start upExperience with Quality Management Systems, including Documentation Management and / or Learning and PerformanceKnowledge of regulations, standards and guidelines associated with Quality Management SystemsExperience in monitoring performance and driving improvementDemonstrated ability in problem solvingCapability to build strong and collaborative partnerships with stakeholders and partners and influence changes to ensure compliant, efficient, and effective operationsExperience working with dynamic cross-functional teamsExperience supporting audits and inspectionsStrong organizational skills and ability to manage multiple tasks at one time, ability to follow assignments through to completion and meet timelinesStrong communication skills, both written and oralDemonstrated ability to work as a team player and independentlyWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models, including remote and hybrid work arrangements, where possibleSalary Range83,842.00 USD - 98,328.00 USD

Salary : $83,842 - $98,328