Senior Associate Quality Assurance / Aseptic Coach

BioSpace; Thousand Oaks (CA); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Comprehensive employee benefits package

Retirement and Savings Plan

Flexible work models

Job summary

A biopharmaceutical company located in Thousand Oaks is seeking a Senior Associate Quality Assurance. This role involves providing quality oversight in Drug Product manufacturing and supporting compliance and quality systems. Ideal candidates should have a minimum of a high school diploma with corresponding GMP experience. The position offers collaborative work culture, career development opportunities, and competitive benefits, reinforcing the company's mission to serve patients.

Qualifications

• High school/GED with 4 years of GMP experience, or Associate's with 2 years, or Bachelor's with 6 months.
• Strong organizational skills and ability to manage multiple tasks.

Responsibilities

• Ensure quality oversight of Drug Product Manufacturing.
• Perform real-time aseptic oversight on the manufacturing floor.
• Support quality-related decision-making.

Skills

GMP experience

Coaching

Problem-solving

Effective communication

Aseptic behaviors

Education

High school/GED

Bachelor's degree in Biochemistry, Biology, Chemistry

Job description

Senior Associate Quality Assurance

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.

• 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.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The quality assurance professional we seek is an employee with these qualifications.

Basic Qualifications

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

Preferred Qualifications

• 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

Benefits

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.

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.