Quality Assurance Specialist - PGS Worldwide

PGS Worldwide is actively seeking a skilled Quality Systems Specialist to support ongoing projects for an Aerospace leader remotely. This is an initial 8-month contract-to-hire opportunity and I will respond immediately to all qualified candidates.

Job Description:

·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

Requirements:

·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, andthe ability to determine phase appropriate requirements
·Knowledge of Regulatory Compliance and ICH Guidelines

Job ID: 730373

Military veterans and transitioning military members are encouraged to apply to all PGS Worldwide positions. All of our jobs are military-friendly, and we work with leaders in Aerospace who rely on your military expertise to support mission-critical programs nationwide. As a Veteran Founded company, we know that the military has given you the skills and training you need to succeed in positions like this, and we want to support your success in the civilian sector however we can. We thank you for your service, and humbly offer our own in return by helping you take your career to the next level.