SUMMARY:
Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision.

FUNCTIONS:

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

EDUCATION:

• Doctorate or Masters + 2 years of directly related experience.
• Bachelors + 4 years of directly related experience.
• Associates + 8 years of directly related experience.
• High school/GED + 10 years of directly related experience.
• Preferred: Microbiology, Biology or Life Sciences

PREFERRED QUALIFICATIONS:
Knowledge in:

• Environmental Monitoring, Microbial Identification (Micro ID), Critical Utilities (CU) monitoring.
• Sampling monitoring:  equipment and techniques.
• Data trending and evaluation.
• Microbiological testing methods and standards for clean rooms and controlled environments.
• Aseptic behavior in manufacturing areas to prevent contamination.
• Facility cleaning and disinfection.
• Familiarity with the regulatory requirements and quality standards for environmental monitoring in the pharmaceutical industry: Annex 1, FDA Guidance, ISO-14644-1, USP.
• Word processing, presentation, database, and spreadsheet application skills (Smartsheets, Microsoft Office: word, power point, and excel).
• Ability to use software tools and statistical techniques to visualize, interpret, and report on environmental/CU monitoring data.
• Ability to analyze trend reports and environmental/CU data to identify areas for improvement.
• Hands on experience in electronic systems for instance: Documentation platforms such as Veeva, Spotfire, LIMS, Maximo.
• Use of artificial intelligence tools such as data analytics and large language models.
• Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.
• Specific responsibilities include but are not limited to:
  • Supports the AML site GMP buildings Environmental Monitoring Process.
  • Generates Environmental Monitoring and Critical Utilities trend reports.
  • Participates and or Leads Risk Assessments to evaluate sampling sites for routine monitoring of GMP areas.
  • Provides assessments to change control records, deviations, audit processes that need support form the Environmental Control perspective.
  • Participate in forums such as the Environmental Control Network, Aseptic Council and or Contamination Control Network as assigned.
  • Attends AML GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation.
  • Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations.
  • Supports Continuous Improvement initiatives, programs, and projects.
  • Collaborates cross functionally as needed to ensure the Quality Management System processes are performed in alignment with established procedures.
  • Alerts senior management of quality, compliance, supply, and safety risks.
  • Supports internal/external audits and inspections as needed.

SKILLLS:

• 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.

WORK METHODOLOGY:

• Professional services contract
• Full time job
• Full on site job
• Location: Juncos, PR
• Expected hiring month: June 2026
• Initial contract term: 6 months
• Number of openings: 3
• Administrative shift  (weekends and overtime may also be required).