Contractor Specialist QA

Looking for someone with a background, preferably in microbiology and aseptic techniques, not necessarily an expert.

Data Management and Reporting:

• Managing data, environmental, and lab data reports.
• Generating Environmental Monitoring and Critical Utilities trend reports.

Environmental Monitoring Support:

• Supporting the site Environmental Monitoring Process.
• Participating in and/or leading Risk Assessments.
• Assessing sampling sites for routine monitoring of GMP areas.
• Providing assessments to change control records, deviations, and audit processes.

Networking and Collaboration:

• Participating in forums (Environmental Control Network, Aseptic Council, Contamination Control Network).
• Attending Quality system forums and Management Review meetings.

Compliance and Continuous Improvement:

• Ensuring facilities, equipment, materials, processes, and products comply with cGMP practices.
• Supporting Continuous Improvement initiatives.
• Collaborating cross-functionally to ensure Quality Management System processes align with established procedures.
• Alerting senior management of quality, compliance, supply, and safety risks.
• Supporting internal/external audits and inspections.

Educational Requirements:

• Doctorate/Master's degree and 3 years experience
• Bachelor's degree and 5 years experience
• Associate's degree and 10 years experience
• High school diploma/GED and 12 years experience

Knowledge & Skills:

• Life Sciences (Biology, Microbiology):
• Environmental Monitoring, Microbial Identification, Critical Utilities monitoring
• Sampling monitoring equipment and techniques
• Data trending and evaluation
• Microbiological testing methods and standards
• Aseptic behavior
• Facility cleaning and disinfection
• Regulatory requirements and quality standards (Annex 1, FDA Guidance, ISO-14644-1, USP)
• Word processing, presentation, database, and spreadsheet application skills (Smartsheets, Microsoft Office)
• Software tools and statistical techniques for data visualization and reporting
• Analyzing trend reports and data to identify improvement areas
• Electronic systems (Veeva, Spotfire, LIMS, Maximo)
• Artificial intelligence tools (data analytics, large language models)
• Strong communication, facilitation, and presentation skills
• Bilingual in English and Spanish

What is the last date for applying to the job?

Which countries are accepted for this remote job?