Lab Manager - Quality

Rockline Industries; Morristown (TN); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Rockline Industries in Morristown, TN seeks a QC Lab Manager to oversee daily laboratory activities, directing analyses of raw materials, finished products, in-process and development samples.

The role requires a four-year degree in chemistry, microbiology, or biology (MS preferred) and 7+ years of supervisory experience, with strong background in cGMP, regulatory affairs, method development and validation.

Qualifications

• Four-year Degree in Chemistry, Microbiology or Biology required; MS preferred.
• 7+ years of lab supervisory/management experience; pharma/medical device/cosmetic a plus.
• Experience with regulatory bodies (FDA/other) and cGMP practices.

Responsabilités

• Directs all activities of the laboratory in analyses of materials and products.
• Leads, trains, and evaluates laboratory staff; participates in hiring.
• Develops and approves procedures, protocols, and validation studies.
• Interacts with QA, Operations, and customers on analytical issues.
• Oversees audits and CAPA investigations; ensures cGMP compliance.
• Maintains a safe, compliant lab environment and RRITE values.

Connaissances

Lab supervision

Regulatory knowledge

Analytical chemistry

LEAN principles

cGMP knowledge

Formation

Bachelor's degree in Chemistry/Microbiology/Biology

MS preferred

Outils

Analytical instruments

Laboratory information systems

Description du poste

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/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 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

(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 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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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