QC Lab Manager
Overview
At the Vitamin Shoppe, Every Body Matters! We are dedicated to inspiring health and wellness one life at a time.
Our goal is to inspire you to take control of your health. We provide products, knowledge and motivation to help you live your healthiest life. We believe that everybody matters. These words are more than our tagline; they're our reason for being. For us, it's not just about the vitamins; it's about the individual lives that we touch every day. We believe in giving personal attention and doing all we can to help you achieve your unique goals. Our associates (we call them health enthusiasts) are eager and very highly trained to help you find what you need, and ensure that you have an exceptional experience every time you visit the Vitamin Shoppe.
Come be a part of something great and join our family of Health Enthusiasts!
The QC Laboratory Manager's purpose is to ensure efficient and effective management of the QC and microbiology resources. The objective is to supervise the quality control laboratory and microbiology operations with tasks such as scheduling, resource management, technical review, and compliance related issues. To plan, direct and implement improvements in systems, processes, and procedures to increase efficiency, productivity and quality in the laboratory.
Responsibilities
Essential Functions:
Manage scheduling of laboratory staff, resources and procedures to support manufacturing needs & their priorities.
Manage the Microbiological and Environmental Monitoring testing requirements and trends, ensuring compliance to all applicable regulations.
Implement new analytical technologies per Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed.
Coach and mentor lab personnel to optimum performance, and recruit and interview qualified applicants, ensure appropriate new-hire training and orientation, and provide on-going training and development for the team.
Ensure completion of all testing, including raw materials, in-process, final release, stability, environmental, biological and special project/protocol testing in a timely manner that achieves fulfillment to commitments.
Implement and continuously improve quality systems to ensure compliance with SOPs, specifications, and applicable regulations.
Monitor testing techniques and review accuracy of records and documentation generated.
Perform routine walk-throughs and compliance checks to verify adherence to quality guidelines.
Interact with inspectors and customers in regulatory audits to represent area of responsibility.
Maintain inventory and submit P.O of chemical reagent and lab supplies, when needed to the purchasing department.
Monitor hazardous waste storage and final disposal from the labs through the facility /EHS lead.
Maintain inventory chemical stockrooms and gas supplies.
Manage departmental budget for supplies, service contracts, and maintenance.
Provide routine maintenance of laboratory instruments and oversee maintenance and repairs performed by third parties.
Coordinate the raw materials testing program for both internal and outside laboratories.
Interact with outside lab to resolve technical-analytical problems including OOS/OOT investigations. Work with QA ensuring a complete and up-to-date documentation of all lab investigations.
Coordinate with manager of analytical Services to implement new methods, execute technical transfer of methods, and new raw material evaluations.
Maintain Material Safety Data Sheets.
Verify that all physical & chemical analyses meet the specifications of each raw material and bulk product before disposition for manufacturing.
For Raw materials and bulks, compare and verify the versions of the master formula in the ManuForce system are in accordance with description of the finished products' supplement label.
Work with QA for the effective change control including ManuForce system for all specifications.
Issue the raw material and bulk disposition documentation and provide disposition in ManuForce. .
Responsible for issuing UPR (use pending release), and Release status for all raw materials and bulks through the ManuForce system.
Ensures that all analysts follow the methods as developed and qualified.
Maintains the SOPs and ensures the training for the laboratory personnel.
Manages the contract labs' quality agreements, invoices, and performance.
Qualifications
Required Education/Work
Experience:
Master's Degree in Chemistry/Analytical Chemistry or Biology with at least 5-7 Years in Quality Laboratory or
BS/BA in Chemistry or Biology related field with 7-10 years' experience in Quality Laboratory
GMP experience is required.
Must have QC Microbiology laboratory experience for non-steriles
Required Knowledge:
Knowledge of lab operations including microbiology under 21 CFR parts 11, 110 and 111.
Full understanding of cGMP requirements, USP requirements and FDA guidance. Exposure to international guidances will be a plus.
Full understanding of Environmental Microbiology and Microbiology requirements for non-sterile nutraceuticals
Proven technical troubleshooting and problem solving abilities.
Ability to manage multiple projects in the pharmaceutical industry or contract laboratory environment
Ability to implement quality systems and process improvements
Proven ability to cope with a dynamic work environment
Precise understanding of OOS/OOT programs and the applicable investigation and data integrity requirements by the FDA.
Skills & Ability:
Excellent multi-tasking, analytical and decision making skills with the ability to troubleshoot and identify root causes and systematically solve problems both practical and theoretical
Strong English and Spanish communication skills, both oral and written with the ability to facilitate meetings, conduct training and to present information in an advisory capacity.
Interact with manufacturing, planning and purchasing personnel.
Interact with outside lab technical and management to ensure proper management of turn arounds of testing results and investigations.
Interact with customers and corporate personnel
#CB
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
At the Vitamin Shoppe, Every Body Matters! We are dedicated to inspiring health and wellness one life at a time.
Our goal is to inspire you to take control of your health. We provide products, knowledge and motivation to help you live your healthiest life. We believe that everybody matters. These words are more than our tagline; they're our reason for being. For us, it's not just about the vitamins; it's about the individual lives that we touch every day. We believe in giving personal attention and doing all we can to help you achieve your unique goals. Our associates (we call them health enthusiasts) are eager and very highly trained to help you find what you need, and ensure that you have an exceptional experience every time you visit the Vitamin Shoppe.
Come be a part of something great and join our family of Health Enthusiasts!
The QC Laboratory Manager's purpose is to ensure efficient and effective management of the QC and microbiology resources. The objective is to supervise the quality control laboratory and microbiology operations with tasks such as scheduling, resource management, technical review, and compliance related issues. To plan, direct and implement improvements in systems, processes, and procedures to increase efficiency, productivity and quality in the laboratory.
Responsibilities
Essential Functions:
Manage scheduling of laboratory staff, resources and procedures to support manufacturing needs & their priorities.
Manage the Microbiological and Environmental Monitoring testing requirements and trends, ensuring compliance to all applicable regulations.
Implement new analytical technologies per Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed.
Coach and mentor lab personnel to optimum performance, and recruit and interview qualified applicants, ensure appropriate new-hire training and orientation, and provide on-going training and development for the team.
Ensure completion of all testing, including raw materials, in-process, final release, stability, environmental, biological and special project/protocol testing in a timely manner that achieves fulfillment to commitments.
Implement and continuously improve quality systems to ensure compliance with SOPs, specifications, and applicable regulations.
Monitor testing techniques and review accuracy of records and documentation generated.
Perform routine walk-throughs and compliance checks to verify adherence to quality guidelines.
Interact with inspectors and customers in regulatory audits to represent area of responsibility.
Maintain inventory and submit P.O of chemical reagent and lab supplies, when needed to the purchasing department.
Monitor hazardous waste storage and final disposal from the labs through the facility /EHS lead.
Maintain inventory chemical stockrooms and gas supplies.
Manage departmental budget for supplies, service contracts, and maintenance.
Provide routine maintenance of laboratory instruments and oversee maintenance and repairs performed by third parties.
Coordinate the raw materials testing program for both internal and outside laboratories.
Interact with outside lab to resolve technical-analytical problems including OOS/OOT investigations. Work with QA ensuring a complete and up-to-date documentation of all lab investigations.
Coordinate with manager of analytical Services to implement new methods, execute technical transfer of methods, and new raw material evaluations.
Maintain Material Safety Data Sheets.
Verify that all physical & chemical analyses meet the specifications of each raw material and bulk product before disposition for manufacturing.
For Raw materials and bulks, compare and verify the versions of the master formula in the ManuForce system are in accordance with description of the finished products' supplement label.
Work with QA for the effective change control including ManuForce system for all specifications.
Issue the raw material and bulk disposition documentation and provide disposition in ManuForce. .
Responsible for issuing UPR (use pending release), and Release status for all raw materials and bulks through the ManuForce system.
Ensures that all analysts follow the methods as developed and qualified.
Maintains the SOPs and ensures the training for the laboratory personnel.
Manages the contract labs' quality agreements, invoices, and performance.
Qualifications
Required Education/Work
Experience:
Master's Degree in Chemistry/Analytical Chemistry or Biology with at least 5-7 Years in Quality Laboratory or
BS/BA in Chemistry or Biology related field with 7-10 years' experience in Quality Laboratory
GMP experience is required.
Must have QC Microbiology laboratory experience for non-steriles
Required Knowledge:
Knowledge of lab operations including microbiology under 21 CFR parts 11, 110 and 111.
Full understanding of cGMP requirements, USP requirements and FDA guidance. Exposure to international guidances will be a plus.
Full understanding of Environmental Microbiology and Microbiology requirements for non-sterile nutraceuticals
Proven technical troubleshooting and problem solving abilities.
Ability to manage multiple projects in the pharmaceutical industry or contract laboratory environment
Ability to implement quality systems and process improvements
Proven ability to cope with a dynamic work environment
Precise understanding of OOS/OOT programs and the applicable investigation and data integrity requirements by the FDA.
Skills & Ability:
Excellent multi-tasking, analytical and decision making skills with the ability to troubleshoot and identify root causes and systematically solve problems both practical and theoretical
Strong English and Spanish communication skills, both oral and written with the ability to facilitate meetings, conduct training and to present information in an advisory capacity.
Interact with manufacturing, planning and purchasing personnel.
Interact with outside lab technical and management to ensure proper management of turn arounds of testing results and investigations.
Interact with customers and corporate personnel
#CB
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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