Career CategoryOperations
Job DescriptionSr Associate Quality Assurance What you will doLet's do this. Let's change the world. In this vital role you will be responsible to ensure that operations products are manufactured, tested, stored and distributed according to Good Manufacturing Practices (cGMP).
- Supports and audits and inspections preparation, planning, execution and response activities as well as facilitating completion of compliance and regulatory requests
- Provides QA oversight for IQA and ensures area readiness as the IQA compliance representative. Support IQA quality events, change controls and risk assessments.
- Supports ATO Management Review activities and metric control plan adherence
- May perform review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformances, CAPAs, Change Control records and validations. May also support execution of these tasks.
- Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
- Supports that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
- Supports Continual Improvement initiatives, programs and projects
- Alerts management of quality, compliance, supply and safety risks
- Represents the Quality Assurance during audits and inspections
- Completes required assigned training to permit execution of required tasks
- Responsible for complying with Good Manufacturing Practices and Good Documentation Practices
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications:High school/GED + 4 years of Quality Assurance work experience
OR
Associate's + 2 years of Quality Assurance work experience
OR
Bachelor's + 6 months of Quality Assurance work experience
OR
Master's
Preferred Qualifications:- Demonstrated knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulations.
- Experience with Quality Management System (QMS) processes
- Knowledge of quality metrics, Management Review processes, and continuous improvement methodologies.
- Experience supporting regulatory inspections, partner audits, and internal quality audits.
- Experience serving as a Quality Assurance representative within a manufacturing or quality organization.
- Excellent written and verbal communication skills, including the ability to present information to leadership and regulatory inspectors.
What you can expect of usAs 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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range82,081.95USD -111,052.05 USD
