Specialist QA - Remote

Overview

The Specialist QA will support the Environmental Monitoring Process and assist in data management and reporting within the pharmaceutical and medical device industries.

In Short

• Supports the site Environmental Monitoring Process.
• Manages environmental and laboratory data.
• Generates trend reports for Environmental Monitoring and Critical Utilities.
• Participates in Risk Assessments for GMP areas.
• Provides assessments for change control records and audit processes.
• Participates in Environmental Control forums and Quality system meetings.
• Ensures compliance with cGMP practices and regulations.
• Supports Continuous Improvement initiatives.
• Collaborates cross-functionally for Quality Management System processes.
• Alerts management of quality and compliance risks.

Requirements

• Doctorate or Master's degree with 3 years of experience, or Bachelor's with 5 years, or Associate's with 10 years, or High school diploma with 12 years of experience.
• Background in Life Sciences (Biology, Microbiology).
• Knowledge in Environmental Monitoring and Microbial Identification.
• Experience with data trending and evaluation.
• Familiarity with regulatory requirements for environmental monitoring.
• Proficient in Microsoft Office and data analysis tools.
• Strong communication skills, bilingual in English and Spanish.

Benefits

• Confidentiality of applicant information according to EEO guidelines.