QC Specialist, Microbiology

Amgen • West Greenwich, RI

3d • $100,450 - $135,904

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Requirements

• High school diploma / GED and 10 years of Quality, Microbiology or Operations experience OR Associate’s degree and 8 years of Quality, Microbiology or Operations experience OR Bachelor’s degree and 4 years of Quality, Microbiology or Operations experience OR Master’s degree and 2 years of Quality, Microbiology or Operations experience OR Doctorate degree

Nice To Haves

• Microbiology degree and/or microbiology laboratory experience associated with microbial identification.
• Understanding of manufacturing processes associated with contamination control
• Professional work experience in a fast-paced, flexible GMP laboratory.
• Leadership ability, support routine and non-routine testing, method and equipment troubleshooting.
• Ability to generate, investigate, and close deviations and analytical result assessments in Veeva.
• Ability to generate and document validation protocols and reports.
• Ability to evaluate data for trends and document corrective actions.
• Experience performing aliquoting of samples aseptically.
• Operation, maintenance experience with laboratory equipment.
• Ability to generate and revise methods and SOPs within CDOCs.
• Demonstrated proficiency with electronic systems capturing consumables, testing procedures, results, and investigations (SAP, LIMS, LMES, CIMS, Veeva, etc.).
• Demonstrated understanding and use of Maximo (Work order System)
• Ability to manage and lead Operational Excellence initiatives including Level and Flow, 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.

Responsibilities

• Lead QC Laboratory investigations in the areas of microbiology and environmental monitoring
• Support Manufacturing deviation investigations from microbiology perspective
• Document microbial assessment reports
• Revise GMP documents associated with microbiology investigations and other activities to support CAPA and Change Controls
• Support process improvements and other microbiology projects
• Support the global network for initiatives and projects that impact microbiology groups
• Support and document trending analysis, validation protocols/reports, and change controls
• Generate complete, accurate, and concise laboratory documentation using electronic systems, such as LMES, LIMS, CIMS and laboratory notebooks
• Train on assays that support microbial identification activities
• Operate and maintain specialized laboratory equipment and instrumentation
• Lead the team to ensure the daily/weekly tasks are performed
• 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.

Benefits

• A 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 plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level