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Quality Systems Senior Associate, Document Management and Supplier Quality
2525 223rd Street Southeast Bothell, WA 98021 US
Job Description
The role is responsible for the administration of the document control, training and supplier quality processes within the electronic Quality Management System (eQMS). The incumbent will partner closely with users of the QMS to create, revise, and maintain controlled documents and associated training required to support GxP operations. Additionally, this role will support the activities required to qualify and maintain qualified GMP suppliers.
Key Responsibilities include:
- 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
PREFERRED EXPERIENCE:
- Minimum of 5 years in document control experience
- Minimum of 5 years of experience working within an eQMS
- 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 Education: BSc degree with 3 years’ experience in a relevant field (eg GMP biopharmaceutical operations)
Pay Rate Range: $35-49/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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