Quality Lab Manager

Imagine... a career where you are responsible for implementing processes and overseeing daily activities and quality systems for a FDA-regulated manufacturing facility. You will be challenged with ensuring that lab testing provides the highest quality of analytical support for manufacturing while maintaining compliance with regulatory guidelines, cGMP requirements and safety regulations. We are seeking a Quality Lab Manager like you to join our team! Bring your skills and talents to Iatric where you'll have the opportunity to ensure product and consumer safety while driving continuous improvement across the lab. Join a team committed to safety, quality, integrity and excellence in everything we do!

Here's what your day will look like:

• Directs all activities of the laboratory in the analyses of raw materials, finished products, in-process, and product
  development samples.
• Interacts with vendors for purchasing lab consumables, scheduling lab equipment maintenance.
• Develops, reviews, revises and approves new/revised procedures, work instructions, protocols, reports,
  specifications, analytical method development, validation, and transfers.
• Provides leadership, management, and training to all laboratory employees.
• Conducts ongoing associate assessments and recruiting/hiring of new talent.
• Oversees and approves internal and external laboratory investigations.
• Offers technical guidance for NCM investigations, deviations, CAPAs, and complaints.
• Communicates with Operations, QA, Sales, Global Purchasing and Customers on all analytical/laboratory-related issues as well as new product support including method transfers/validations.
• Assists in all internal and external quality audits and provides responses to internal and external audit observations.
• Maintains a safe, cGMP-compliant lab environment.

Do you have what it takes?

• Four-year Degree in Chemistry, Microbiology or Biology required; MS preferred.
• A minimum of 7 years of lab supervisory/management experience required. Pharmaceutical, medical device, or cosmetic manufacturing strongly preferred but would consider clinical or related. Technical background in chemical theory, analytical methodology, laboratory instrumentation and computer applications as related to pharmaceutical analysis.
• Seven+ years of experience interacting with regulatory body (e.g. FDA, TGA).
• Experience in Chemistry, microbiology, cGMP, QC, federal/state regulations, mathematical skills, manufacturing processes, method development and validation, financial analysis, sourcing, and budgeting. Additionally, experience in quality systems, strategic planning, LEAN principles, 21CFR parts 210, 211, 820 or CLIA regulations, GLPs, analytical equipment qualification process, analytical equipment maintenance and repair, stability programs, OOS investigation process, CAPA, project management, laboratory design and implementation.