Lab Manager Quality

ESSENTIAL ACCOUNTABILITIES:

The QC Lab Manager is responsible for managing the daily activities for the iatric laboratories. This includes but is not limited to the following:

• 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/Iatrics 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 associates 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 associates inability or impaired ability to perform their job-related tasks could result in a direct threat to the associates safety or the safety of others).

QUALIFICATION REQUIREMENTS: (To perform this job successfully an individual must be able to perform each of the essential accountabilities satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.)

• 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 partsor 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

Required Experience:

Manager