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The Compliance Specialist
Ref No.: 18-07711
Location: Waltham, Massachusetts
Start Date / End Date: 07/09/2018 to 07/04/2019
Work Location: Waltham - MA
Job Title: The Compliance Specialist
Duration: 12 months

The Compliance Specialist provides compliance and quality support for applicable GxP processes within the Quality Management System (QMS). The candidate is involved in the review and disposition of Client products manufactured at CDMO's

Main Responsibilities
Maintain compliance requirements for established QMS processes and procedures
Provide support to product disposition process by reviewing completed batch documentation and verifying GxP and Client requirements are met
Train and maintain proficiency in using electronic quality systems for managing change control, deviations, CAPA, etc.
Complete analysis, identify issues and provide recommendations for compliance improvements; if applicable, help remediate processes and systems in accordance with company standards and regulatory requirements
Participate on projects or assignments and ensure objectives are appropriately set and met
Demonstrate understanding of and ability to interpret US and international GxP regulations
Interact and coordinate with internal and/or external stakeholders

Qualifications
Works effectively and cooperatively with others - Establishes and maintains good working relationships
Attention to detail, strong verbal and written communications, effective time management, and organizational skills
Ability to multi-task and work in a fast paced and dynamic environment
Driven with a strong focus on goals

Education
Bachelor's degree or equivalent and 2+ years of relevant experience within the Biotech/Pharmaceutical industry