Senior Associate Quality Assurance Aseptic Coach

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 / Aseptic Coach

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 24/7 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.
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.

Additionally:

Must be flexible with shift work (including weekends) and comfortable with gowning requirements to support 24/7 production in a Grade 8 (Clean Room) Drug Product filling facility.

Shifts may vary from 8hrs to 12hrs depending on rotation (Days Swings Graves)

Shift rotations will be required (Days Swings Graves) to support production schedule.

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

Associates 2 years of GMP experience OR

Bachelors 6 months of GMP experience

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 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

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.

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.

Sponsorship for this role is not guaranteed.

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