Company:  Confidential

Job Title: Contract Quality Specialist

Job Number: 78531

Location: San Diego, US

Job Description

As the Quality QMS Specialist-Contractor, your role involves managing the daily document control activities, ensuring adherence to procedures, regulations, and standards. Additionally, you’ll engage in various tasks related to Quality Management Systems as required.

Responsibilities

* Collaborate with relevant internal departments as necessary to ensure efficient processing of new documents, document revisions, and change controls. * Evaluate internal documents before release to ensure compliance with Antares Pharma standards, working closely with document owners or change authors to address any shortcomings. * Assist in managing QMS record storage, including organizing records for transfer to off-site storage or disposal as needed. * Oversee the review of internal documents according to predetermined schedules and external documents upon notification of updates. * Distribute change controls, reports, and other relevant documents to partners at Antares Pharma. * Contribute to the ongoing enhancement of document control and record management processes.

Required Skills

* A minimum of two years of college education coupled with at least three years of experience in either the medical device or pharmaceutical sector, specifically in document and change control management. Candidates with a blend of education and experience will also be considered. * Proficiency in computer skills, particularly in Microsoft Office applications such as Word, Excel, and PowerPoint. * Familiarity with electronic Quality Management System (eQMS) software for document and record management, with an added advantage for those experienced with document control management using MasterControl. * Knowledge of Good Manufacturing Practice (GMP), International Organization for Standardization (ISO), Quality System Regulation (QSR), and other relevant international standards, regulations, directives, and guidance. * Basic familiarity with Computer-Aided Design (CAD) software and the ability to interpret technical drawings. * Experience with document indexing structures, scanning, and high-volume printing. * Demonstrated ability to communicate effectively, both verbally and in writing.Salary: $55/hour

Application Deadline: 2024-06-03

 

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