Sr. Associate Quality Control, Microbiology

About the role

Join Amgens Mission of Serving Patients. In this vital role, you will support the QC Microbiology and Environmental Monitoring team by performing activities including microbial investigations/assessments, microbiological and analytical testing, sample and data management, equipment and instrumentation operation and maintenance, sample and equipment troubleshooting, and the review and authorization of documents and samples while performing in a highly dynamic, team-oriented environment.

Responsibilities

• Perform microbial assessments and other GMP documentation as required (reports, assessments, SOP revisions).
• Support microbial and other QC laboratory investigations.
• Perform Microbiological testing to support GMP operations across ATO.
• Perform Microbiological sample and method qualifications including bioburden, microbial identification, sterility, and other microbiological assays as assigned.
• Perform testing and data review for compendia, non-compendia methods, and routine laboratory procedures.
• Generate complete, accurate, and concise laboratory documentation using electronic systems, such as LMES, LIMS, and laboratory notebooks.
• Operate and maintain specialized laboratory equipment and instrumentation.
• Perform general laboratory housekeeping activities and safety inspections.
• Maintain training compliance and proficiency.
• At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.

Qualifications

• Basic Qualifications:
• High school/GED + 4 years of Quality experience OR
• Associates + 2 years of Quality experience OR
• Bachelors degree and 6 months of Quality, Microbiology or Operations experience OR
• Master's degree
• Preferred Qualifications:
• Professional work experience in a fast-paced, flexible GMP laboratory.
• Leadership ability, to assist with the daily/weekly schedule, routine and non-routine testing and sample collection questions and issues, and equipment troubleshooting.
• Experience executing microbial test methods (i.e. bioburden, microbial identification, growth promotion, qPCR, sterility, etc.).
• Experience supporting Environmental and Clean Utility Monitoring programs.
• Operation, maintenance experience with laboratory equipment.
• Ability to generate and revise methods, reports and SOPs within CDOCs.
• Demonstrated proficiency with electronic systems (LIMS, LMES, CIMS, CDOCS, etc.).
• Ability to generate, update, triage, and close deviations and analytical test result assessments.
• Demonstrated understanding and use of Maximo and the ability to update and complete work orders.
• Ability to manage and lead Operational Excellence initiatives including 5S and Standard Work associated with the testing labs.
• Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively.
• Demonstrated ability to be flexible and adaptable to support business needs.

Pay

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.

Schedule

Full time