- 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 compliant 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.
- Performs other related duties as assigned by management.
- B.S or higher strongly preferred from four-year college or university, or 5 years of related experience and/or training, or equivalent combination of education and experience.
- Extensive Knowledge of 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
- Computer skills required: SAP, Microsoft Office Suite
- Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
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Quality Control Manager - Jupiter, United States - Vetio
Description
About the job Quality Control Manager
Primary Function:
The QC Manager is responsible for all Quality Control functions at Vetios 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:
