Quality Assurance Co-Op - Fall 2022
How will you make an impact?This position requires a highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. The individual will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with Thermo Fisher standards.Essential Responsibilities:Responsible for contributing to key functional, tactical, and operational aspects of VVS operations at the Cambridge site. This includes approval & oversight of MFG and QC activities associated with CAPA, deviations, and other documentation related to MFG and QA operations.Batch Record/Logbook reviewDocument/Label Issuance and archivalQuality support for Critical MFG Operations on the floorInitiation and approval of deviations through TrackwiseProcess improvement initiativesPerform Acceptable Quality Limit (AQL) of Fill Finish vialsEM Data review for Room releaseSupport third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformitiesResponsible for evaluating impact, ensuring adherence to compliance standards, including technical ability to evaluate & approve these quality system elements, as delegated by management.Provides feedback for personnel development.Knowledge, Skill, and Requirements:Enrolled/ studying a degree in Sciences2-5 years of completed university coursework Knowledge of biologic manufacturing, vector manufacturing, fill finish, or label and pack processesStrong interpersonal and communications skills; written and oral.Ability to perform as an individual and part of a team, self-motivatedSolid understanding of US, EU and ROW cGMP guidelines and requirements preferred.Ability to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior specialists or area management.Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environmentAbility to understand operational documents for GMP compliance, accuracy and completeness. Ability to work by influencing a matrix management system and to gain the cooperation of others.Strong client-facing interpersonal skills coupled with a concern for impact.Strong time management and organizational skills.Pragmatic, proactive yet flexible approach in the working environment.Excellent written and oral communication skills both internal and external.Able to manage multiple priorities and demonstrate self-controlAbility to resolve conflict within project teamsDetail Oriented Self-StarterStrong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.Physical Demands:Ability to function in a rapidly changing environment & handle multiple prioritiesA flexible work schedule is requiredAbility to lift up to 25 lbsNote: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.At Thermo Fisher Scientific, each one of our 90, extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.