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Specialist Manufacturing

9 hours ago

New Albany, Ohio, United States BioSpace Full time

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.

Specialist Manufacturing (Quality Record Owner) - External Supply RMD

What You Will Do
Lets do this. Lets change the world. In this role, you will own and execute under minor supervision all the processes related to deviations (minor and major), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications, and Supplier Investigations (EN/SICAR), and Change Control quality records. In addition, it is expected to apply process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support quality records originating from manufacturing sites across the Amgen network. This Specialist Manufacturing will also act as the External Supply representative across functional teams and drive closure of quality records in a timely manner.

Work onsite as a flex commuter in the Amgen facilities may be required according to business needs.

Responsibilities Include, But Are Not Limited To The Following

  • Address and close quality records under the company's quality management system procedures and ensure compliance with regulatory agency requirements.
  • Mentoring and leading of peers in functional areas and Quality Operations in the implementation of investigations of varying complexity.
  • Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance.
  • Monitor, author, and investigate deviations owned by External Supply and implements corrective / preventive actions. Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process.
  • Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.).
  • Manages closure of multiple quality records simultaneously and in a timely matter (Deviations, Change Controls, ENs, SICARs, CAPA, CAPA-EV).
  • Work closely with the suppliers and External Supply peers to address and close critical investigations and Corrective Actions.
  • Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management.
  • Communication of Quality records status to Senior Leadership in multiple forums (as requested); maintaining the metric reporting for performance.
  • May participate in regulatory inspections.
  • Participate in the assessment or implementation of continuous improvement projects or initiatives.
  • Meet deadlines, prioritize work, and communicate effectively.
  • Maintain remote working relationships with colleagues at other Amgen sites.
  • Leads process improvement initiatives.

What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications
Doctorate degree

Or

Masters degree & 2 years of Manufacturing and/or Quality support experience

Or

Bachelors degree & 4 years of Manufacturing and/or Quality support experience

Or

Associates degree & 8 years of Manufacturing and/or Quality support experience

Or

High school diploma / GED & 10 years of Manufacturing and/or Quality support experience

Preferred Qualifications

  • 3+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
  • Live Science and/or Engineering educational background.
  • Project management and technical writing experience.
  • Quality management skills including previous experience managing quality records in Trackwise or a comparable quality system.
  • SAP system knowledge
  • Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
  • Excellent communication skills, both written and verbal in English (including technical writing and presentation skills).
  • Experience presenting to and interacting with representatives of regulatory agencies. Good to have
  • Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
  • Ability to tactfully negotiate and positively influence peers and executive leadership.
  • Previous experience managing external suppliers.

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 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.

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.

Sponsorship

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.