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location: Framingham, Massachusetts
job type: Contract
salary: $29.06 - 34.19 per hour
work hours: 9 to 5
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 re-qualification.
•Perform qualification in a cGMP biotech manufacturing 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 the company'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 our company 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.
Education & Qualifications
•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
•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
•Knowledge of Validation Lifecycle Approach.
skills: Quality control, SOP, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.