Quality Systems Senior Associate, Document Management jobs in United States
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Planet Pharma ยท 17 hours ago

Quality Systems Senior Associate, Document Management

Planet Pharma is a company seeking a Quality Systems Senior Associate to manage document control and training processes within their electronic Quality Management System (eQMS). This role will involve partnering with users to create and maintain controlled documents, oversee training, and support supplier quality activities.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Serve as the Document Coordinator for the document workflows MasterControl. Edit documents to conform to established templates and quality standards including grammar, formatting, and consistency. Partner with stakeholders to ensure document effective dates align with quality requirements and timelines
Serve as the Training Coordinator for the document workflows in MasterControl. Set training due dates, assign training courses to Job Codes, assign Job Codes to applicable Trainees
Oversee MasterControl User management activities including onboarding and offboarding of Users
Provide orientation and training on MasterControl for New Hires to facilitate smooth system adoption
Manage the distribution, tracking, and follow-up of GMP supplier questionnaires
Liaise with material suppliers to address material defects and quality-related concerns
Act as primary point of contact for MasterControl User questions and help requests. Troubleshoot system and document issues with
Work with MasterControl to investigate and remediate system performance

Qualification

Document control experienceEQMS experienceBiotech/pharma/medical devicesMicrosoft WordMicrosoft ExcelMicrosoft PowerPointElectronic systems administrationCustomer serviceBusiness communicationInterpersonal skillsCritical thinkingOrganizational skills

Required

Minimum of 3 years in document control experience
Minimum of 3 years of experience working within an eQMS
3+ years of experience in biotech, pharma or medical devices
Advanced proficiency in Microsoft Word, Excel and PowerPoint
Strong knowledge of English grammar with keen attention for document formatting and cosmetics
Proficiency in using and administering electronic systems
Ability to troubleshoot, diagnose, identify, and resolve issues through effective follow-through
Desire to work with Users and provide excellent customer service
Highly organized, self-motivated critical thinker with strong interpersonal and business communication skills
The desire and ability to work in a fast-paced, start-up environment

Preferred

BSc degree

Company

Planet Pharma

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Planet Pharma is a pharmaceuticals company.

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 Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase