Associate Quality Control

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Location :
Puerto Rico, Texas

Expiry Date :
Mon, 07 Dec 2020 23:59:59 GMT

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Description :
Career Category Quality Job Description Amgen is looking for multiple experienced Associate QC Incoming to join the Quality Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, sophisticated equipment, engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best manufacturing facility in the world. The Role Under general supervision, responsible for one or more of the following activities in Incoming Quality Control including analytical testing, raw material sample and data management, Incoming raw material and components sampling/inspection, clean rooms sanitization/cleaning, raw material sample shipments and batch records review per standard operating procedures or guidelines. SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: – Perform routine inspection of raw materials, components, labels, labeled and packaged raw materials – Perform routine sampling of raw materials, drug substance, drug product, labels, API, tablets – Perform Rapid id testing and/or Functional testing to raw materials/components. – Data entry, review, analysis and reporting of results – Work closely with Supply Chain Procurement, Disposition, Dispensing, Receiving, Shipping and Packaging to ensure daily warehouse operations are well coordinated between each function. – Perform general housekeeping – Operate specialized equipment – Generate/compile quality data and reports (e.g., LIMS, lot track/trace, incidents) – Assist with batch record documentation review – Initiate incidents in LIMS – Clean Room clearance inspection, cleaning and sanitization. – General document coordination and compilation. – Technical knowledge in raw material sampling/inspection, components sampling/inspection and sample shipment per procedures and regulations. – Identify operational issues and process improvement opportunities, identify solutions, lead the effort to address them. – Participate in or lead multi-departmental, cross-functional multi-site projects of moderate scale – Able to train staff in all cGMP and operational functions – May monitor and audit work processes to ensure compliance – Serve as the groups primary point of contact to internal and external customers, for complex operational issue, includes investigating and resolving issues – Assist others in preparation for regulatory inspections and audits – Participate in regulatory inspections and audits – Performs classified area rooms cleaning/sanitization processes and disinfectant solution preparation. Basic Education and Experience Bachelors degree Preferred Qualifications – Educational background in Life Sciences and/or Engineering – Strong skills in systems such as SAP, eBR, LIMS and others – Ability to safely handle and transport hazardous materials. – Must be flexible and adaptable to changing priorities and requirements. – Intermediate mathematical skills – Experience with lab equipment (NIR/TruScan/analytical balances/pipettes, CTM, Instron, Optical, etc.) – Basic understanding of cGMPs – Clear, concise writing skills – Basic problem-solving skills – Ability to interact constructively with peers – Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles – Ability to adhere to regulatory requirements, written procedures and safety guidelines. – Self-motivated – Ability to work as a team player and/or independently. – Ability to evaluate documentation and operations according to company and regulatory guidelines/procedures – Basic word processing, presentation and spreadsheet application skills – Ability to organize work, handle multiple priorities and meet deadlines. – Good communication skills (both written and verbal) – Independently understand, follow and implement basic instructions – Organizational skills – Demonstrate the Amgen Values The benefits Our broad approach is one of the reasons why we are regularly recognized as a Best Place to Work. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program and on-site childcare and fitness facilities you will find us focused on your well-being too. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment, and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 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. Join Us If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. .