Varite
Pay Rate Range - $38.75 - 49.24/hr.
GBaMS ReqID: 10338210
Job Description: • Author equipment qualification/validation packages/protocols for the QCL • Technical review and execution of qualification/validation protocols • Partner with other team members and external equipment vendors regarding qualification issues and equipment operation • Responsible for execution of laboratory computer system validation (CSV) initiatives • Apply knowledge of quality principles, GMPs, federal regulations, corporate standards and practices and local procedures in the development of qualification/validation protocols and equipment lifecycle management • Interact effectively with lab customers, support groups, and team • If applicable, recommend industry best-practice improvements and streamlined quality activities relating to equipment • Potentially serve as equipment and technical resource in the review of CSV technical documents • Originate equipment CSV change controls • Work with management/sponsor/team to multitask, prioritize, and coordinate work to meet customers' needs • Demonstrate problem solving and investigative skills • Ability to make decisions based on CSV and/or equipment knowledge, experience, standard processes, and requirements • Ability to work independently and accurately
This role is to provide equipment lifecycle management support to the Parenteral QCL. This role focuses on the qualification and validation of laboratory equipment with and/or without a computer attached. For that equipment with a computer attached, computer system validation (CSV) activities must be coordinated and actioned to support the equipment teams main support functions. Main support functions include authoring equipment qualification (EQ) packages, leading the EQ process, and providing daily operational support of laboratory equipment by ensuring the equipment is maintained in a qualified state of compliance.
The position requires an understanding of the computer system validation and respective deliverables, corporate quality systems, a detail-oriented quality mentality with an understanding of analytical/micro laboratory equipment or ability to learn that understanding, knowledge of intended use of equipment, and equipment failure modes effects. High-quality skills should include: working with equipment vendors, equipment troubleshooting, ability to prioritize, written and verbal communication, decision making, interpersonal/people, computer application use, and problem solving. Skills: Category Name Required Importance Experience SkillCategoryTest1_MN Desktop Management - Infrastructure Services (IS) Yes 1 2-4 years SkillCategoryTest1_MN Digital : Windows Virtual Desktop Yes 1 2-4 years
Job Description: • Author equipment qualification/validation packages/protocols for the QCL • Technical review and execution of qualification/validation protocols • Partner with other team members and external equipment vendors regarding qualification issues and equipment operation • Responsible for execution of laboratory computer system validation (CSV) initiatives • Apply knowledge of quality principles, GMPs, federal regulations, corporate standards and practices and local procedures in the development of qualification/validation protocols and equipment lifecycle management • Interact effectively with lab customers, support groups, and team • If applicable, recommend industry best-practice improvements and streamlined quality activities relating to equipment • Potentially serve as equipment and technical resource in the review of CSV technical documents • Originate equipment CSV change controls • Work with management/sponsor/team to multitask, prioritize, and coordinate work to meet customers' needs • Demonstrate problem solving and investigative skills • Ability to make decisions based on CSV and/or equipment knowledge, experience, standard processes, and requirements • Ability to work independently and accurately
This role is to provide equipment lifecycle management support to the Parenteral QCL. This role focuses on the qualification and validation of laboratory equipment with and/or without a computer attached. For that equipment with a computer attached, computer system validation (CSV) activities must be coordinated and actioned to support the equipment teams main support functions. Main support functions include authoring equipment qualification (EQ) packages, leading the EQ process, and providing daily operational support of laboratory equipment by ensuring the equipment is maintained in a qualified state of compliance.
The position requires an understanding of the computer system validation and respective deliverables, corporate quality systems, a detail-oriented quality mentality with an understanding of analytical/micro laboratory equipment or ability to learn that understanding, knowledge of intended use of equipment, and equipment failure modes effects. High-quality skills should include: working with equipment vendors, equipment troubleshooting, ability to prioritize, written and verbal communication, decision making, interpersonal/people, computer application use, and problem solving. Skills: Category Name Required Importance Experience SkillCategoryTest1_MN Desktop Management - Infrastructure Services (IS) Yes 1 2-4 years SkillCategoryTest1_MN Digital : Windows Virtual Desktop Yes 1 2-4 years