Lab Manager - Quality

Essential Accountabilities

• 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, and uniform services for lab coat management
• 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.
• Demonstrate commitment to Rockline/Iatric’s RRITE Values of Renew, Respect, Integrity, Teamwork, and Excellence.
• Associates have a direct and important role in ensuring that all work is performed in a safe manner. Effectiveness in carrying out this responsibility is part of each associate’s essential accountabilities.
• Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work, as needed or requested

This position is designated as a Safety-Sensitive (A safety-sensitive position is one in which the associate’s inability or impaired ability to perform their job-related tasks could result in a direct threat to the associate’s safety or the safety of others).

QUALIFICATION REQUIREMENTS:

• 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.

Grade 13