Planet Pharma · 9 hours ago
Quality Systems Specialist
Waltham, MA
Contract
Onsite
Mid, Senior Level
$40/hr - $50/hr
3+ years expPlanet Pharma is seeking a Quality Systems Specialist to support their global Quality Systems and operations. The role involves ensuring compliance with global SOPs, managing change controls, and providing customer support through system and training management.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
Qualification
Required
Minimum of 2 years' experience in a facilities role
High School Diploma or equivalent
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
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
Preferred
Lab experience
Associate's Degree or higher
Highly skilled in Microsoft Office or equivalent suite
Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase