Quality Lab Manager: QC & Compliance Leader

Rockline Industries; Morristown (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Rockline Industries seeks a QC Lab Manager to oversee daily lab operations, including analysis of materials and products, method development, and validation. The role requires leading staff, coordinating with QA and Operations, and ensuring cGMP-compliant practices.

The candidate should have a chemistry/biology background with 7+ years of supervisory experience, and strong familiarity with regulatory requirements such as FDA and CLIA guidelines.

Qualifications

• Bachelor's degree in Chemistry, Microbiology or Biology; MS preferred.
• 7+ years lab supervisory/management experience.
• Experience interacting with regulatory bodies (FDA, TGA).
• Experience in cGMP, QC, 21 CFR parts 210, 211, 820 or CLIA regulations, GLPs.

Responsibilities

• Directs all activities of the laboratory in analyses of raw materials, finished products, in-process, and development samples.
• Provides leadership, management, and training to all laboratory employees.
• Oversees and approves laboratory investigations and CAPAs.
• Communicates with Operations, QA, Sales, and Customers on analytical issues and method transfers/validations.
• Maintains a safe, cGMP-compliant lab environment.

Skills

Lab supervision

LEAN principles

cGMP

Regulatory interactions

CAPA

Project management

Quality systems

Education

Bachelor's degree in Chemistry, Microbiology or Biology

MS preferred

Tools

Laboratory instrumentation

Analytical software

Job description

Rockline Industries seeks a QC Lab Manager to oversee daily lab operations, including analysis of materials and products, method development, and validation. The role requires leading staff, coordinating with QA and Operations, and ensuring cGMP-compliant practices.

The candidate should have a chemistry/biology background with 7+ years of supervisory experience, and strong familiarity with regulatory requirements such as FDA and CLIA guidelines.