Senior Associate Quality Assurance

About the role

The Sr. Associate Quality Assurance position supports Amgens Quality Assurance program under the Plant QA organization. This 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.

Responsibilities

• Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual
• Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments
• Electronic batch review
• GMP Document (SOPs/FORMs) revision review/approval
• Quality support and approval of minor deviations
• Electronic Batch Record (MES) documentation revisions and approvals
• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.

Requirements

• Must be flexible with shift work (including weekends) and comfortable with gowning requirements to support 24/7 production in a Grade 8 (Clean Room) Drug Product filling facility.
• Shifts may vary from 8hrs to 12hrs depending on rotation (Days, Swings, Graves)
• Shift rotations will be required (Days, Swings, Graves) to support production schedule

Qualifications

• Basic Qualifications:
• High school/GED + 4 years of GMP experience OR
• Associates + 2 years of GMP experience OR
• Bachelors + 6 months of GMP experience OR
• Master's
• Preferred Qualifications:
• Bachelors Degree in Biochemistry, Biology, Chemistry, or related science field
• 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)
• Display leadership attributes and drive improvement initiatives
• Solid understanding and application of aseptic behaviors and principles

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

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

Shifts may vary from 8hrs to 12hrs depending on rotation (Days, Swings, Graves) to support production schedule.