Specialist QA- 35471 (3rd Shift- Batch Record Review)

CIS International•Juncos, PR

6d•Onsite

About The Position

Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision. This role involves reviewing and approving various documents related to manufacturing processes, validation, investigations, and change controls. The Specialist QA will also represent QA on teams, lead investigations and audits, and ensure compliance with quality programs. They will collaborate with cross-functional teams, interact with regulatory agencies, and utilize strong data analysis and communication skills.

Requirements

Doctorate or Master’s + 2 years of Scientific experience.
Bachelors + 4 years of Scientific experience.
Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the Amgen Values/Leadership Practices.