QA Sr. Associate I - Evening 12 hour Shift (6:00pm-6:00am)

Career Category

Job 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.

Sr Associate QA

What you will do

Lets do this. Lets change the this role The Sr. Associate Plant QA for the new Amgen Advanced Assembly and Final Product Operation facility will be part of the Quality Assurance Floor Support team providing QA oversight to GMP operations in the Device Assembly and Finished Product Packaging Area. The Sr. QA Associate will support multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by using the deviation and CAPA management procedure in conjunction with other procedures as applicable to facilitate decision-making with Production IQA and other groups as needed. Advising Production on proper documentation as needed and performing other duties as assigned. This role will require local presence at the New Albany facility near Columbus Ohio.

• Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
• Ensure regular presence in device assembly and packaging areas to provide oversight to GMP operations and quality systems.
• Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
• Lead mentor and coach Operations and support personnel on quality matters while driving the site Quality culture.
• Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place
• Perform finished product checks during (commercial) production runs
• Compile and review batch records for lots assembled packaged and labeled at AOH in preparation for batch disposition.
• Own review and approve controlled documents including Standard Operating Procedures (SOPs) Work Instructions and Forms.
• Review and approve Deviation CAPA and Change Control records.
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Support Lean Transformation and Operational Excellence initiatives
• Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.

Basic Qualifications:

High school/GED 4 years of Quality and/or GMP Manufacturing experience

Or

Associates 2 years of Quality and/or GMP Manufacturing experience

Or

Bachelors 6 months years of Quality and/or GMP Manufacturing experience

Or

Masters

Preferred Qualifications:

• Scientific degree in Life Sciences Physical Sciences Applied Engineering or Manufacturing Technologies
• Experience in and knowledge of GMP/GCP operations or similarly regulated industry
• Affinity with digital innovation data sciences and Quality engineering
• Experience with raw material receipt inspection & sampling
• Highly effective verbal and written communication skills strong interpersonal skills
• Great attention to detail and high degree of accuracy in task execution and GMP documentation
• Ability to complete tasks autonomously providing updates to senior management and identifying potential issues
• Strong organizational skills including ability to follow assignments through to completion
• Direct experience with Enterprise Resource Management software (SAP) TrackWise CDOCS etc.

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.

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.

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