Job Information
Amgen Senior Associate Quality Assurance - Thousand Oaks, CA in Thousand Oaks, California
467383BR
Auto req ID:
467383BR
Company:
Amgen
Job Code:
Pharmaceutical Pharmaceutical
Job Description:
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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,
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
Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
Position Title:
Senior Associate Quality Assurance - Thousand Oaks, CA
Job Category:
Manufacturing
Minimum Education Required:
High School/GED
City*:
Thousand Oaks
Additional Qualifications/Responsibilities:
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
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
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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.
Salary Range
86,928.00 USD - 106,536.00 USD
State*:
California
Salary Range:
$75,000-$100,000