Job Description

Job Title: Quality Lab Manager

Location: Morristown, TN (Can Provide Relocation!)

A leading producer of cross-industry FDA-regulated products is expanding their team! They are looking for a Quality Lab Manager to direct all laboratory activities and oversee site quality systems.

Job Responsibilities:

• Lab Management: Oversee all laboratory activities, including analysis of raw materials, finished products, and in-process samples.
• Vendor Interaction: Manage purchasing of lab consumables and scheduling of equipment maintenance.
• Procedure Development: Develop, review, and approve procedures, work instructions, protocols, and reports.
• Leadership: Provide training and management to lab employees, conduct assessments, and recruit new talent.
• Investigations: Oversee internal and external lab investigations and offer technical guidance for various quality issues.
• Communication: Liaise with Operations, QA, Sales, Global Purchasing, and Customers on lab-related issues and new product support.
• Audit Assistance: Assist in quality audits and respond to audit observations.
• Compliance: Maintain a safe, cGMP-compliant lab environment.

Qualifications:

• Education: Four-year degree in Chemistry, Microbiology, or Biology (MS preferred).
• Experience: Minimum of 7 years in lab supervisory/management roles, preferably in pharmaceutical, medical device, or cosmetic manufacturing.
• Regulatory Interaction: Experience with regulatory bodies like the FDA or TGA.
• Skills: Proficiency in chemistry, microbiology, cGMP, QC, federal/state regulations, method development, financial analysis, and project management.
• Must be authorized to work in the US without Visa Sponsorship

This role is ideal for someone who is passionate about quality and compliance in a regulated environment and enjoys leading a team to ensure the highest standards of product and consumer safety. Does this sound like a role you or someone you know might be interested in? If so, please apply directly in!

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