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!
