Environmental Monitoring Process Specialist
$68,600–$114,300 year
On-siteRochester, Michigan, United States
Job Summary
Recognize and anticipate Environmental Monitoring needs, coordinate Quality Control activities for product transfers, and perform product quality reviews. Conduct testing, audits, and inspections to identify non-compliance, then develop corrective action plans and maintain accurate compliance records. Prepare and submit deviation and compliance reports to management and regulatory bodies while providing training on testing systems and techniques. Collaborate with cross-functional teams to ensure compliance across operations and monitor regulatory changes to update programs accordingly. Occasional weekend work and modified hours may be required to support production.
Required Qualifications
- Bachelor's degree with 0+ years of experience, OR an Associate's degree with 4 or more years of experience, or a high school diploma (or equivalent) with 6 or more years of relevant experience
- Strong understanding of regulatory requirements and compliance standards
- Excellent attention to detail and organizational skills
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Effective written and verbal communication skills
- Must not be allergic to Penicillin
- Must be able to complete aseptic gowning training and be able to work gowned
- Candidate must be able to understand principles of scientific writing and design of experiments
- Must be authorized to be employed in the U.S. by any employer
- U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future
- This position requires permanent work authorization in the United States
- Occasional weekend work may be required, also modified hours are required at times to support production
Desired Qualifications
- Demonstrated working knowledge and understanding of EM procedures, sample processing / analysis, and lab calculations
- Working knowledge of contemporary analytical techniques
- Knowledge of Good Manufacturing Practices {also cGMP}, validation principles, audit techniques, and working knowledge of statistics
- Experience with audit processes and corrective action plans
- Strong problem-solving skills
- Knowledge of drug/device product requirements
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity
- Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
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