Associate Quality Control West Greenwich, RI
West Greenwich, RI - USA
Job Summary
What you will do
Lets do this. Lets change the this vital role you will provide support for QC Centralized Raw Material Testing in the Wet Chemistry Laboratory at Amgen Rhode Island. The role will be based out of Amgen Rhode Island and will work under the guidance of the hiring manager. It is an administrative shift Monday through Friday.
The Raw Material Centralized Testing team provides analytical expertise in testing raw materials to meet Amgen specifications and ensure a constant supply of raw materials for Amgen products. The laboratory employs a variety of test methodologies from basic wet chemistry identifications and titrations to complex instrumental analysis of a substances critical parameters. The team provides these crucial services for the entire Amgen production network to ensure only the highest quality raw materials are used to create products for our patients.
Responsibilities:
Follow safety guidelines cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
Generate complete accurate and concise laboratory documentation using electronic systems and laboratory notebooks
Ensures that facilities equipment materials organization processes procedures and products follow cGMP practices and other applicable regulations
Operate laboratory equipment and instrumentation
Performs review and approval of assays documents and records
Supports Continual Improvement initiatives
Alerts management of quality compliance supply and safety risks
Participate in laboratory investigations
Perform general laboratory housekeeping activities
Completes required assigned training to permit execution of required tasks
Performs additional duties as specified by management
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The dedicated professional we seek is a great teammate with these qualifications.
Basic Qualifications:
High school diploma / GED and 2 years of Quality or Operations experience OR
Associates degree and 6 months of Quality or Operations experience OR
Bachelors degree
Preferred Qualifications:
Experience performing analytical testing per Methods and/or Compendia
Experience with QC analytical systems and/or Quality systems
Excellent interpersonal written and verbal communication skills with all levels within the organization
Ability to work in a team matrix environment and build relationships with partners
Experience leading teams or projects
Identify manage and champion innovative projects to advance productivity and enable LEAN principles across different functions
Experience in auditing and defending processes procedures and decisions during regulatory inspections
Demonstrated innovative thinking and ability to transform work organizations
Strong technical writing skills within a highly regulated environment
Exposure to Operational Excellence initiatives
Demonstrated ability to navigate through ambiguity and provide a structured problem solving
Demonstrated ability to deliver on schedule
Required Experience:
IC
About Company
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