QA Specialist 35382

Title: Specialist QA (Environmental Monitoring) 3605982

Positions Available: 3

Location: Juncos

Work Schedule: Onsite – Administrative Shift

Eligibility: Open to Puerto Rico residents

Position Summary

We are seeking experienced and detail-oriented professionals to support the Quality Assurance Environmental Monitoring Program within a regulated pharmaceutical manufacturing environment. The selected candidates will perform critical QA activities under minimal supervision to ensure compliance with cGMP regulations, environmental control standards, and internal quality systems.

The ideal candidate will possess strong technical knowledge in environmental monitoring, microbiology, contamination control, data trending, and regulatory compliance within the pharmaceutical or biotechnology industry.

Preferred Qualifications

Educational Background

Preferred Degree Concentration In One Of The Following Areas

• Microbiology
• Biology
• Life Sciences
• Related scientific discipline

Candidates should demonstrate knowledge and/or hands-on experience in the following areas:

• Environmental Monitoring (EM)
• Microbial Identification (Micro ID)
• Critical Utilities (CU) Monitoring
• Sampling techniques and monitoring equipment
• Data trending, analysis, and evaluation
• Microbiological testing methods and standards for cleanrooms and controlled environments
• Aseptic practices and contamination prevention in manufacturing areas
• Facility cleaning and disinfection procedures
• Pharmaceutical regulatory requirements and quality standards, including:
• Annex 1
• FDA Guidance
• ISO 14644-1
• USP standards
• Software applications and data management tools, including:
• Microsoft Office Suite (Word, Excel, PowerPoint)
• Smartsheet
• Veeva
• Spotfire
• LIMS
• Maximo
• Statistical tools and software used for visualization, interpretation, and reporting of environmental and critical utilities data
• Trend analysis and identification of improvement opportunities
• Artificial intelligence tools, including data analytics platforms and large language models (LLMs)

Additional Skills

• Strong written and verbal communication skills
• Presentation and facilitation skills
• Fully bilingual in English and Spanish
• Strong analytical and problem-solving capabilities

Key Responsibilities

• Support GMP Environmental Monitoring processes across AML site facilities
• Generate Environmental Monitoring and Critical Utilities trend reports
• Participate in and/or lead risk assessments for routine monitoring sampling locations
• Provide Environmental Control assessments for:
• Change controls
• Deviations
• Audit processes
• Participate in forums and committees such as:
• Environmental Control Network
• Aseptic Council
• Contamination Control Network
• Present environmental and critical utilities data during Quality System and Management Review meetings
• Ensure compliance of facilities, equipment, materials, procedures, and products with cGMP regulations and applicable quality standards
• Support continuous improvement initiatives and projects
• Collaborate cross-functionally to ensure Quality Management System (QMS) compliance
• Escalate quality, compliance, supply, and safety risks to senior management
• Support internal and external audits and regulatory inspections

Essential Functions

• Review and approve product Manufacturing Procedures (MPs)
• Review and approve process validation protocols and reports
• Serve as QA representative on incident triage teams
• Approve Environmental Characterization reports
• Support release activities for sanitary utility systems
• Review and approve planned incidents
• Represent QA on New Product Introduction (NPI) teams
• Lead investigations and site audits
• Own and maintain site quality program procedures
• Act as designee for QA Manager on local CCRB activities
• Review and approve Risk Assessments
• Support automation-related initiatives
• Support facilities and environmental programs
• Review and approve Work Orders
• Review and approve EMS/BMS alarms
• Approve non-conformance investigations and CAPA records
• Review and approve Change Controls
• Perform lot disposition and authorize lots for shipment

Education & Experience Requirements

Candidates must meet one of the following combinations of education and directly related experience:

• Doctorate degree OR
• Master’s degree with 2+ years of directly related experience OR
• Bachelor’s degree with 4+ years of directly related experience OR
• Associate degree with 8+ years of directly related experience OR
• High School Diploma/GED with 10+ years of directly related experience

Competencies & Skills

• Strong project management skills
• Excellent organizational and multitasking abilities
• Ability to lead and coordinate cross-functional teams
• Strong leadership, influencing, and negotiation skills
• Advanced technical knowledge within area of expertise
• Ability to collaborate with internal and external stakeholders
• Strong understanding of:
• Manufacturing processes
• Distribution
• Quality Assurance (QA)
• Quality Assurance Laboratory (QAL)
• Validation
• Process Development
• Experience interacting with regulatory agencies
• Advanced data trending and compliance evaluation skills
• Strong proficiency in:
• Word processing
• Database management
• Spreadsheet applications
• Presentation tools
• Ability to work independently and interact effectively across multiple organizational levels
• Strong written and oral communication skills
• Demonstrated alignment with Amgen Values and Leadership Practices