Specialist Quality Control Support - Empower at Amgen
Holly Springs, North Carolina, USA -
Full Time


Start Date

Immediate

Expiry Date

27 Nov, 25

Salary

126322.0

Posted On

27 Aug, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Pharmaceutical Sciences, Laboratory Techniques, Computerized Systems, Teams, Control Testing, Empower, Chemistry, Technical Reports, Communication Skills, Technical Writing

Industry

Pharmaceuticals

Description

BASIC QUALIFICATIONS:

  • High school diploma / GED and 10 years of Quality Analytical testing experience OR
  • Associate’s degree and 8 years of Quality Analytical testing experience OR
  • Bachelor’s degree and 4 years of Quality Analytical testing experience OR
  • Master’s degree and 2 years of Quality Analytical testing experience OR
  • Doctorate degree

PREFERRED QUALIFICATIONS:

  • Experience working in a GMP Quality Control Chemistry Laboratory.
  • Degree in Scientific Field such as Chemistry or Pharmaceutical Sciences or related scientific field.
  • 4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
  • Experience with Chemistry Quality Control testing, including but not limited to: HPLC, UPLC, Concentration and USP-NF methods.
  • Strong Leadership, Collaboration and Communication skills.
  • Strong knowledge of laboratory techniques.
  • Proficient in the use of Empower, method templates, and sample sets in Empower.
  • Knowledge of related regulatory/industry considerations, compliance issues, templating and/or scientific discovery.
  • Strong written and verbal communication skills including technical writing and presentation.
  • Experience with equipment and method validation, verification, and transfer including the change control process.
  • Interact effectively with variety of communication and working styles and ability to work well in teams.
Responsibilities

Let’s do this. Let’s change the world. In this pivotal role, you will support ANC Quality Control as the site’s Business Process Owner (BPO) for Empower. Reporting directly to the Manager of Quality Control Support, you will serve as a subject matter expert for QC Empower based systems. Your expertise will help drive the startup, validation, and ongoing success of the QC Chemistry team utilizing the Empower based systems and enable manufacturing excellence. Because this role is tightly integrated with manufacturing operations, occasional extended hours, shift work, or weekend support for troubleshooting may be required.
Working under minimal supervision, the successful candidate will contribute to both startup and daily operations of the QC organization by:

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