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Apply to Specialist QA- 35382 (Microbiology Focus/ Environmental Monitoring)
SUMMARY:
Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision.
FUNCTIONS:
Knowledge in:
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.
- 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
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.
- 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.
- 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).