Senior Associate Quality Assurance

16 hours ago


Louisville, United States National Guard Employment Network Full time
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. In this vital role you will focus on the quality delivery within the production workplace.

Responsibilities:
Perform receipt, manufacturing, storage, distribution, and Facilities & Engineering documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Perform cGMP process, procedure, document and record review, approval and tracking, including but not limited to Deviations, CAPAs, Change Controls, and Validations. May also support execution of these tasks.
Perform routine Quality Assurance assessments of site operations and provide direct oversight.
Support Labeling and Packaging Operations including incoming raw material inspection and manufacturing oversight.
Represent the Quality Unit during audits and inspections as needed.
Support internal/external audits and inspections as part of the audit/inspection team as needed.
Perform additional duties as specified by management

Additional Qualifications/Responsibilities

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.

Basic Qualifications:

High school/GED + 4 years Quality experience OR
Associate's + 2 years Quality experience OR
Bachelor's + 6 months Quality experience OR
Master's
Preferred Qualifications:

Ability to interpret and apply cGMP and GDP
Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry
Good written and oral communication
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, including remote and hybrid work arrangements, where possible

Salary Range
83,842.00 USD - 98,328.00 USD

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