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Quality Assurance Specialist

Company: Infotree Service Inc
Location: Cambridge
Posted on: May 4, 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 [email protected] 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.

Keywords: Infotree Service Inc, Cambridge , Quality Assurance Specialist, Other , Cambridge, Massachusetts

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