Qa Specialist (32900) - 1828178
๐ Job Opportunity: Quality Assurance Specialist 32900 (Drug Substance) ๐
๐ Location: Juncos, PR (Onshore, 100% Onsite work with administrative shifts) ๐
๐ฉโ๐๐จโ๐ Educational/Software Requirements:
- Doctorate degree or Master's degree and 3 years of directly related experience
- OR Bachelor's degree and 5 years of directly related experience
- OR Associate's degree and 10 years of directly related experience ๐๐ผ
- Preferred Qualifications: Experience in batch record review, DAI process, and familiarity with PASx/MES application, MAXIMO, SAP, and LIMS. ๐ป๐
๐ Description:
As a Quality Assurance Specialist, you will perform essential duties under minimal supervision, supporting Amgen's Quality Assurance program. This includes reviewing and approving product Master Production Records (MPs), validating protocols and reports for manufacturing processes, participating in incident triage teams, approving Environmental Characterization reports, releasing sanitary utility systems, and more. ๐๐๐ง
๐ Competencies/Skills:
- Project management skills ๐
- Strong organizational skills, including the ability to follow assignments through to completion ๐
- Initiate and lead cross-functional teams ๐
- Enhanced skills in leading, influencing, and negotiating ๐ค
- Strong knowledge in the area of expertise ๐ง
- Collaborate and coordinate with higher-level outside resources ๐
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development ๐๐ผ
- Demonstrate the ability to interact with regulatory agencies ๐ค
- Strong word processing, presentation, database, and spreadsheet application skills ๐ป๐
- Strong communication (both written and oral), facilitation, and presentation skills ๐ฃ๏ธ๐ข
- Strong skills in working independently and effectively interacting with various levels ๐คน
- Advanced data trending and evaluation ๐
- Ability to evaluate compliance issues โ๏ธ
- Demonstrate the Amgen Values/Leadership Practices ๐๐ผ
๐ Additional Requirements:
- Availability for non-standard shifts, including nights and weekends. ๐๐
- Experience in batch record review, DAI process, and familiarity with PASx/MES application, MAXIMO, SAP, and LIMS. ๐๐ง
๐ Join us in Shaping the Future of Quality Assurance in Drug Substance Manufacturing! ๐
Apply now and be part of a team dedicated to excellence and innovation. ๐๐