Senior Associate Quality Assurance / Aseptic Coach

Amgen • Thousand Oaks, CA

9d

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. Senior Associate Quality Assurance What you will do Let’s do this! Let’s change the world! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements. Duties include but are not limited to: Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments, Responsible for performing real-time aseptic oversight and coaching of filling activities on the manufacturing floor. Support real-time troubleshooting and triage with quality and aseptic compliance. Support quality related decision making involving non-routine interventions and documentation. Electronic batch record review GMP Document (SOPs/FORMs) revision review/approval, Review and approval of electronic Maintenance documentation Work Order/Job Plans. Quality support and approval of minor deviations, Electronic Batch Record (MES) documentation revisions and approvals Support predominantly second/third shift work Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.

Requirements

• High school/GED + 4 years of GMP experience OR Associate’s + 2 years of GMP experience OR Bachelor’s + 6 months of GMP experience

Nice To Haves

• Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field.
• Experience with coaching, delivering feedback, and/or leadership.
• Familiarity with Drug Product aseptic processing requirements.
• Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
• Experience managing projects through to completion meeting timelines.
• Ability to evaluate documentation and operations according to company procedures.
• Experience working with Quality Systems
• Strong organizational skills and ability to manage multiple tasks at one time
• Effective communication skills (both written and verbal)
• Demonstrated ability to work as both a team player and independently
• Display leadership attributes and drive improvement initiatives
• Solid understanding and application of aseptic behaviors and principles

Responsibilities

• Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning)
• 100% Manual Visual Inspection support
• ASP/AQL performance, and QA Oversight Assessments
• Responsible for performing real-time aseptic oversight and coaching of filling activities on the manufacturing floor.
• Support real-time troubleshooting and triage with quality and aseptic compliance.
• Support quality related decision making involving non-routine interventions and documentation.
• Electronic batch record review GMP Document (SOPs/FORMs) revision review/approval
• Review and approval of electronic Maintenance documentation Work Order/Job Plans.
• Quality support and approval of minor deviations
• Electronic Batch Record (MES) documentation revisions and approvals Support predominantly second/third shift work
• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.

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