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Quality Systems Specialist

Waltham, MA 02451

Posted: 06/06/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 607098 Is job remote?: No Country: United States

Job Description

This is a hybrid position with onsite days as Tuesday, Wednesday and Thursday.
KEY AREAS OF JOB ACCOUNTABILITY:(list of key objectives and quantifying standards)

·The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs.

Position details:

·Assist in governance of Quality System applications, including harmonization of processes across sites

·Assist in gathering requirements for improvements and ongoing maintenance by participating in meeting/workshops with Site Process Owners and business SMEs

·Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues

·Follow-up on requests, issues, and projects and report statuses to manager/ working teams

·Initiate and manage change controls, with associated documentation requirements, to completion

·Ensure system is maintained in a validated state by participating in periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with Quality Systems

·Support investigation, escalation, and resolution of issues identified on the system

·Support validation activities as requested; this includes but is not limited requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports

·Support manager with ongoing communication from vendor/IT where required

·Provide customer support through system and training management and onboarding of new users

·Generate metrics to support quality systems

·Support regular system updates/ releases and provide assessment of and recommendations regarding new features

·Maintain key user-related documentation and ensure it is kept up-to-date as new functionalities are enabled, created and/or modified

 

ACADEMIC/TECHNICAL QUALIFICATIONS:

·Bachelor’s degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality background

·Minimum of 3-6 years of experience in a high volume commercial / clinical pharma / healthcare facility

·Proficient in MS Word, Excel, and Quality System processes. Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus.

·Understanding and working knowledge of US FDA and European regulatory requirements and GAMP, and the ability to determine phase appropriate requirements

·Knowledge of Regulatory Compliance and ICH Guidelines

Pay ranges between $40-50/hr based on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Waltham, MA

Discover exciting job opportunities in the vibrant area surrounding Waltham, Massachusetts! Known for its rich history, picturesque scenery, and bustling economy, Waltham offers job seekers a unique blend of innovation and tradition. Home to renowned universities, cutting-edge technology companies, and a thriving cultural scene, this city has something for everyone. Explore job listings in this region and unlock the door to a career filled with growth, charm, and endless possibilities. From strolling along the Charles River to catching a game at Fenway Park, there's no shortage of enchanting experiences waiting for you in the Waltham area. Start your job search today and embark on a rewarding career journey in one of the most inviting locations in the Northeast.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.