Planet Pharma · 1 day ago
Quality Systems Senior Associate, Document Management and Supplier Quality
Bothell, WA
Full-time
Onsite
Senior Level
$35/hr - $49/hr
5+ years expPlanet Pharma is a company focused on quality management in biopharmaceutical operations, and they are seeking a Quality Systems Senior Associate to manage document control, training, and supplier quality processes within their electronic Quality Management System. The role involves partnering with users to maintain controlled documents, oversee training, and ensure compliance with GMP standards.
BiotechnologyHealth CarePharmaceutical
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
Required
Administration of the document control, training and supplier quality processes within the electronic Quality Management System (eQMS)
Partner closely with users of the QMS to create, revise, and maintain controlled documents and associated training required to support GxP operations
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
Work with MasterControl to investigate and remediate system performance
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
Minimum of 5 years in document control experience
Minimum of 5 years of experience working within an eQMS
Preferred Education: BSc degree with 3 years' experience in a relevant field (eg GMP biopharmaceutical operations)
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