Sr Associate Plant QA
2 weeks ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Sr Associate Plant QA (12 hour 6pm-6am)
Live
What you will do
Lets do this. Lets change the world. In this role as Senior Associate Plant QA, you will be working in a shift system; you will be mainly responsible for providing QA guidance and support to AOH production, and you will be performing Quality Batch Record Review of all commercial batches labelled and packed at AOH. Next to that, you will provide support in different QA related projects/systems.
In this role, you will be in direct contact with a wide range of partners, and you will be accountable for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering.
Senior Associate Plant QA Night Shift
The Sr. Associate Plant QA for the new Amgen Advanced Assembly and Final Product Operation facility will be part of the Quality Assurance Floor Support team providing QA oversight to GMP operations in the Device Assembly and Finished Product Packaging Area. The Sr. QA Associate will support multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by using the deviation and CAPA management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with Production, IQA, and other groups, as needed. Advising Production on proper documentation as needed and performing other duties as assigned. This role will require local presence at the New Albany facility near Columbus, Ohio.
Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.Ensure regular presence in device assembly and packaging areas to provide oversight to GMP operations and quality systems.Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take placePerform finished product checks during (commercial) production runsCompile and review batch records for lots assembled, packaged and labeled at AOH in preparation for batch disposition.Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.Review and approve Deviation, CAPA, and Change Control records.Participate in self-led inspections and provide support during internal / external regulatory inspections.Support Lean Transformation and Operational Excellence initiativesAdhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals.WinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications. Basic Qualifications: High school/GED + 4 years of Quality and/or GMP Manufacturing experienceOr Associates + 2 years of Quality and/or GMP Manufacturing experience OR Bachelors + 6 months years of Quality and/or GMP Manufacturing experience OR Master's Preferred Qualifications:Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing TechnologiesExperience in and knowledge of GMP/GCP operations or similarly regulated industryAffinity with digital innovation, data sciences and Quality engineeringExperience with raw material receipt, inspection & samplingHighly effective verbal and written communication skills, strong interpersonal skillsGreat attention to detail and high degree of accuracy in task execution and GMP documentationAbility to complete tasks autonomously, providing updates to senior management, and identifying potential issuesStrong organizational skills, including ability to follow assignments through to completionDirect experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.ThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. Amgen offers a Total Rewards Plan comprising 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 including: 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.-
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