Quality Control Manager

Company: Vetio Animal Health
Location: Jupiter
Posted on: May 11, 2022

Job Description:

The QC Manager is responsible for all Quality Control functions at Vetio's Jupiter, FL development and manufacturing facility. This includes ensuring GMP compliance of the Quality Control Laboratory, leading Analytical Method Development and Validation projects, providing support for Quality Control Testing including release and stability testing, and ensuring execution and robust completion of OOS investigations, among other things. The QC Manager manages a team of QC lab analysts and QC floor technicians, along with key programs, like Stability, Instrument Calibration, and Raw Material Testing.

Key Responsibilities:
Manage QC Laboratory and QC Floor personnel
Set-up and maintain Quality Control Laboratory Instrument qualification, calibration, and maintenance programs
Ensure quick turn-around time for lab release testing. Determine and implement ways to improve efficiency
Manage DI water system testing to ensure compliance to USP water standards
Author Quality Control and Quality Assurance Standard Operating Procedures
Review and Approve laboratory notebooks, stability protocols, method protocols, and OOS investigations
Serve as back-up approval for QIRs and CAPAs to Quality Manager
Lead Investigator in OOS investigations
Manage Stability Program including initiating study, pulling samples, updating summary sheets, performing testing, and investigating of results
Lead Neogen micro program including writing methods, training, and maintaining equipment.
Perform back-up HPLC testing of finished products and stability samples utilizing HPLC
Manage contract testing laboratories
Author and approve method development and validation protocols and reports as required during new product development
Participate in Validation efforts including cleaning, equipment, and process validations
Lead and support Investigations including deviations, out of specification, and CAPAs
Ensure laboratory is complaint with all GMP and OSHA requirements
Identify areas of improvement including safety, efficiency, and compliance
Serve as back-up for Raw Material Sampling and Micro Testing
Lead analytical discussions with clients
Author Raw Material Specifications and Testing Requirements
Lead role in new product testing implementation.

Skills & Knowledge Required:
B.S or higher strongly preferred
Extensive Knowledge FDA CFR 210 and 211 requirements
At least 5 years' experience managing a Quality Control and/or Quality Assurance group
GMP Professions certification (Plus)
Experience with communicating with customers and participating in customer projects
Experience leading or participating in regulatory audits with the FDA and other agencies

Keywords: Vetio Animal Health, Jupiter , Quality Control Manager, Executive , Jupiter, Florida