Lab Manager - Quality

Rockline Industries, people who make it right•Morristown, TN

3d•Onsite

About The Position

The QC Lab Manager is responsible for managing the daily activities for the iatric laboratories. This includes but is not limited to directing all activities of the laboratory in the analyses of raw materials, finished products, in-process, and product development samples. The role involves interacting with vendors for purchasing lab consumables, scheduling lab equipment maintenance, and uniform services for lab coat management. A key responsibility is developing, reviewing, revising, and approving new/revised procedures, work instructions, protocols, reports, specifications, analytical method development, validation, and transfers. The manager will provide leadership, management, and training to all laboratory employees, conduct ongoing associate assessments, and handle recruiting/hiring of new talent. This position also oversees and approves internal and external laboratory investigations, offers technical guidance for NCM investigations, deviations, CAPAs, and complaints. Communication with Operations, QA, Sales, Global Purchasing, and Customers on all analytical/laboratory-related issues, as well as new product support including method transfers/validations, is essential. The role assists in all internal and external quality audits and provides responses to audit observations. Maintaining a safe, cGMP-compliant lab environment is crucial. The position requires demonstrating 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, and effectiveness in carrying out this responsibility is part of each associate’s essential accountabilities. Contributing to a cooperative working effort by demonstrating a willingness to perform other job-related work, as needed or requested, is also expected. This position is designated as a Safety-Sensitive position, meaning 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.

Requirements

Four-year Degree in Chemistry, Microbiology or Biology required
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.
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.

Nice To Haves

MS preferred

Responsibilities

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