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Qc Associate I
4 months ago
The Associate Quality Control (QC) position will provide support for QC Centralized Raw Material Testing in the Instrucmentatio 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 substance’s 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**:
- Comply with 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 comply with 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
**Basic Qualifications**:
- Bachelor’s degree
- OR
- Associate’s degree and 4 years of Quality or Operations experience
- OR
- High school diploma / GED and 6 years of Quality or Operations experience
**Preferred Qualifications**:
- Experience executing 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
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 people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s 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.
