Senior Associate QA
Senior Associate QA
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$ 102972 - 102972
1 Vacancy
Job Description
Career Category
QualityJob Description
Join Amgens Mission of Serving Patients
At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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
Lets do this! Lets change the world! The Sr. Associate Quality Assurance position supports Amgens 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 inc. Inspection support ASP and QA assessments
- Electronic batch record review
- SOP revision approval
- Maximo System - Work order job plan approvals
- Quality support and approval of minor deviations
- MES revisions and approvals
- Provide support for 24/5 Manufacturing
Responsibilities will include evaluation of compliance issues providing recommendations and assuring progress of quality records to completion. The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The vital attribute professional we seek is a type of person with these qualifications.
Basic Qualifications:
- High school/GED 4 years of Quality experience OR
- Associates 2 years of Quality experience OR
- Bachelors 6 months of Quality experience OR
- Masters
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)
- 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 well 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
Apply now and make a lasting impact with the Amgen team.
In 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 deadline
Amgen 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.
As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.
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.
.Salary Range
84323.00 USD - 102972.00 USDRequired Experience:
Senior IC
Employment Type
Full-Time
