Specialist QA

Amgen • West Greenwich, RI

1d

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. 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. Specialist QA What you will do Let’s do this. Let’s change the world. In this vital role you will provide Quality Assurance support for Quality Control. This position will work cross-functionally with site Manufacturing, Facility & Engineering and Quality, to monitor and drive continuous improvement and support multiple types of Quality Records. Further, they will work with respective Global Networks to represent site Quality Control. Responsibilities include: Support analytical records, deviations and CAPA records. Support site audits and inspections and responses to agencies as required Reporting metrics and trending and provide statistical evaluations of alert levels Provide recommendations for improvements based on any trends Author, data verify and approve applicable quality documents Own site procedures, support site investigations, and support the metric control plan Contribute to QC systems initiatives and responsibilities including and not limited to LMES qualifications and LIMS templating Participate and contribute in QC site inspection readiness initiatives 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 self-starter with these qualifications. Basic Qualifications: High school diploma / GED & 10 years of Quality and/or Manufacturing experience OR Associate’s degree & 8 years of Quality and/or Manufacturing experience OR Bachelor’s degree & 4 years of Quality and/or Manufacturing experience OR Master’s degree & 2 years of Quality and/or Manufacturing experience OR Doctorate degree

Requirements

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

Nice To Haves

• Bachelor's Degree
• 3+ years experience in the biotechnology or pharmaceutical industry
• Experienced in TRA, CAPA, Change Control
• Strong communication skills (written and oral), facilitation and presentation skills
• Strong organizational skills and ability to multi-task
• Team oriented
• Experienced in leading projects and teams
• Owning records and driving task completion under minimal supervision

Responsibilities

• Support analytical records, deviations and CAPA records.
• Support site audits and inspections and responses to agencies as required
• Reporting metrics and trending and provide statistical evaluations of alert levels
• Provide recommendations for improvements based on any trends
• Author, data verify and approve applicable quality documents
• Own site procedures, support site investigations, and support the metric control plan
• Contribute to QC systems initiatives and responsibilities including and not limited to LMES qualifications and LIMS templating
• Participate and contribute in QC site inspection readiness initiatives

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
• Education Level: High school or GED