Environmental Monitoring (EM) Team Lead

Global Blockchain Talent; Monroe (NC); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a QC Microbiology/EM Team Lead to oversee critical quality control processes in a fast-paced pharmaceutical environment. This role demands expertise in microbiological testing and environmental monitoring, ensuring compliance with regulatory standards. The ideal candidate will lead a team, implement strategies for operational excellence, and collaborate across departments to maintain high-quality service. If you are a proactive leader with a passion for quality assurance and a commitment to safety, this opportunity offers a chance to make a significant impact in a growing organization.

Qualifications

• Minimum 4 years of experience in a quality control role.
• Strong knowledge of EM and microbiological testing.

Responsibilities

• Oversee microbiology and EM quality control aspects.
• Ensure compliance with FDA regulations and quality systems.

Skills

Organizational Skills

Communication Skills

Technical Writing

Root Cause Analysis

Problem-solving

Team Development

Education

BS/BA in Pharmaceutical Sciences

BS/BA in Chemistry

BS/BA in Biology

Tools

Spreadsheets

Databases

Job description

Career Opportunities with Glenmark Pharmaceuticals Inc.

A great place to work.

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Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd., is a leading innovator in discovering new molecules, including NCEs and NBEs, with eight molecules in clinical development stages. The company is rapidly expanding its US generics business and plans to venture into the innovative market.

Glenmark employs over 10,000 people across more than 60 countries, with twelve manufacturing facilities, five R&D centers, and operations in the US, EU, India, and Brazil. The company is positioned for significant growth both domestically and internationally, aiming to emerge as a top research-based pharmaceutical firm.

POSITION SUMMARY:

The QC Microbiology/EM Team Lead oversees and guides the Microbiology and Environmental Monitoring (EM) aspects of quality control, ensuring compliance with Glenmark's quality systems and regulatory standards such as FDA 21 CFR, USP, and EU Annex-1.

This role operates in a fast-paced, FDA-regulated pharmaceutical environment. The incumbent must possess thorough knowledge of EM and microbiological testing, including sampling and analysis of utilities like water, gases, and steam. Responsibilities include ensuring testing compliance, growth performance, contamination checks, and environmental sampling of water, surfaces, and air. The position requires full on-site presence.

Operational Excellence:

• Model Glenmark’s principles and promote adherence to the company's code of conduct.
• Implement strategies and monitor team KPIs aligned with corporate goals.
• Communicate progress and challenges effectively.
• Lead projects, manage resources, and create relevant metrics.
• Utilize spreadsheets and databases for data tracking, reporting, and decision-making.
• Make key decisions regarding laboratory projects and resource allocation.
• Motivate and develop team members.
• Perform routine testing, inventory management, and equipment calibration.
• Address laboratory issues, recommend corrective actions, and ensure validation and compliance of equipment.
• Review GMP data, analyze trends, and verify equipment logs.

Compliance:

• Stay updated on regulatory standards and industry trends.
• Ensure laboratory and cleanroom compliance, and prepare for audits.
• Support SOP updates and continuous improvement initiatives.
• Investigate quality events, perform root cause analysis, and manage CAPAs.
• Maintain investigator training and track quality metrics.
• Ensure systems compliance with cGMPs and regulations.
• Assist in implementing site changes and preparing reports.
• Conduct self-audits and address audit findings.

Stakeholder Collaboration:

• Work with other departments to deliver quality services.
• Manage laboratory supply procurement and costs.
• Coordinate with suppliers to ensure inventory levels and reduce waste.
• Inform management of supply issues and analyze usage patterns.

Safety:

• Ensure team adherence to safety policies.
• Use PPE appropriately during lab activities.

Education & Experience:

Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology, or equivalent. At least 4+ years of relevant experience.

Knowledge and Skills:

• Strong organizational and multitasking skills.
• Excellent communication and technical writing abilities.
• Proficiency in root cause analysis tools.
• Interpersonal skills to work across organizational levels.
• Ability to read, write, and execute SOPs.
• Certification in Microbiology/EM investigations preferred.
• Problem-solving and troubleshooting skills.
• Experience in human resource management and team development.
• Ability to assess safety and environmental risks.

Leadership Attributes:

Ability to work independently and collaboratively, managing multiple projects with flexibility. Must be a technical expert with excellent communication skills.

Other Requirements:

Ability to lift up to 30 lbs and work in various temperature and humidity conditions.