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Quality Assurance Specialist

Company: Infotree Service
Location: Somerville
Posted on: May 1, 2021

Job Description:

Company DescriptionInfotree's approach to every employee and customer is based around making a positive impact. We focus on over-servicing, continuous improvement and a high-quality culture. We're passionate about making successful matches for our employees and customers across the globe. Infotree prides itself in our proven track record and innovative culture with 100% focus on the employees and customers.Job DescriptionPlease rush your resumes at priya.t@ or feel free to reach me at 734-928-2464.Objectives:Support projects and initiatives within the Oncology and External Supply Small Molecule (ESSM) Quality - US Region organization to ensure Quality Compliance with GxP regulations and quality/technical agreements.Support the successful execution of regulatory body visits, both internally and at Contract Manufacturing Organizations (CMOs), by supporting the pre-inspection activities, overseeing the fulfilment of requests during the inspection, and coordinating post-inspections activities as assigned.Accountabilities:Performs or supports the execution of the following activities:Ensure consistent application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US.Tracking of required corrective actions resulting from self-assessments or inspection readiness activities.Participate as an integral member of the Inspection Readiness team and support during all internal, vendor and Alliance/Corporate Partner compliance or regulatory audits/inspections of Oncology and (ESSM) - US Region departments.Perform weekly monitoring of quality systems for any adverse compliance trends and escalate any risks to management.Support the Oncology and ESSM US Region Document Management and Training process owner in th the development and implementation of training curriculums, and develop training material for local procedures.Support the collection of pertinent compliance-related information for Annual Product Reviews (APR) and/or Periodic Product Reviews (PQR).Support the Supplier Qualification Program with up-to-date information to ensure the accuracy of data used for audit planning, GMP certificate renewals and generation of the Approved Supplier List.Receive overall project direction from management but completes most work independently.Independently write new Oncology and ESSM Quality procedures and revise existing procedures.Complete required training and keep training files current.Additional tasks and duties as assigned.Education, Behavioral Competencies and Skills:Bachelor of Science (BS) degree and 3+ years' experience in QA or related compliance area in the pharmaceutical/biotech industry.Knowledge of cGMP regulations for US, EU and other markets including audit knowledge and skills.Effective time management, detail-oriented work style, and superior at teamwork and collaboration.Excellent organizational, presentation development and delivery skills.Proficient computer, verbal and written communication skills.Ability to handle multiple tasks concurrently and in a timely fashion.Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.Must be able to read, write and converse in English.Must display eagerness to learn and continuously improve.Positive work attitude that supports teamwork and continuous improvement.Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint, Learning/Document Management Systems and Trackwise.Wrist and hand motion (e.g. typing, writing).Additional InformationAll your information will be kept confidential according to EEO guidelines.SummaryType:ContractFunction: Quality AssuranceSDL2017

Keywords: Infotree Service, Somerville , Quality Assurance Specialist, Other , Somerville, Massachusetts

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