Tag: validation

Project Leader IV (IT) || Bridgewater, NJ || Type-15-Months Contract ||$60-65/hr

ashishsisodiya45 September 1, 2020
Job Role- Project Leader IV (IT)

Employment Type-1-year contract
Pay rate-$60-65/hr
Location-Bridgewater, NJ
Description:

The primary purpose of this position is to function within the Information Solutions Department as a leader of the design, development, testing, documentation, validation, and support of approved IS business projects that will facilitate the development and management of systems within the Industrial Operations (IO) business process area with respect to information capture, storage, analysis and reporting. A person in this position may lead projects that are local, regional or global in scope, and that have extensive impact on the business. Examples of the types of systems that the individual will work with include data acquisition systems, document management systems, web applications, Laboratory Information Management Systems, manufacturing automation systems, SAP, etc. The majority of the positions responsibilities are related to system implementation tasks such as Business case development; Resource management (including proactive assignment of resources to IS projects); Leadership of project implementation teams; Development of project plans and day to day management of IS projects; Process design, business data, process, and workflow modeling; Software selection; Interaction with Sr. Business Analysts and Business Analysts who may manage day to day tasks at a more detailed level; Managing IS and other project team resources across multiple projects to get projects completed; Change management; Management of project budgets via capital and deferred software funds; Establishment and maintenance of a common framework to support application development, including project management standards, software configuration control, change management, user support and training, testing procedures, validation, and quality assurance; Coordinated reporting and presentation of project status, resource allocation, and other project-related information to IS management..

Years of Experience: 0 – 3 Years

 
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Quality Control ScientistII || Framingham, MA || Type-6-month Contract ||$38-40/hr

ashishsisodiya45 August 1, 2020
Job Role- QC Scientist II

Employment Type-6-month contract
Pay rate-$38-40/hr
Location-Framingham,MA

Position Summary


Quality Control Validation Scientist I is responsible for the qualification activities, following SOPs and regulations including Data Integrity, related to one or more of the following areas: IQ, OQ, PQ and requalificatio

Core Responsibilities
• Perform qualification in a cGMP biotech facility managing multiple complex qualification projects and providing technical assistance to less experienced team members.
• Write, review and approve qualification protocols and reports as well as execute protocol. Resolve protocol discrepancies and deviations.
• Evaluates new technologies platforms for implementation in the QC Laboratories.
• Ensure GMP compliance of all activities performed.
• Represent QC Validation in internal and external audits as required.
• Ensure appropriate facility support and provide technical expertise with regards to equipment.
• Review standard operating procedures.
• Maintain positive relationship and network effectively across sites and organizations.
• Provide project oversight and participate in cross-functional teams.
• Practice safe work habits and adhere to Genzyme’s safety procedures and guidelines. An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
• Perform other additional job related duties as required.
• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Skills:

• Knowledge of Validation Lifecycle Approach.
• Knowledge of Validation Data Integrity Principals
• Ability to present technical data.
• Ability to work independently on scientific projects.
• Scientific technical writing ability authoring and reviewing SOPs, qualification protocols and technical reports.
• Experience troubleshooting of assay and equipment issues

Education:

• Bachelor’s degree in Life Sciences discipline and 5 years of experience in cGMP lab environment, or
• Master’s degree in Life Sciences discipline and 3 years’ experience in cGMP lab environment.
• PhD in Life Sciences discipline and 0-3 years’ experience in cGMP lab environment

 

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