Quality Systems Sr. Associate, Document Management & Supplier Quality

Pride Health is seeking a Quality Systems Sr. Associate, Document Management & Supplier Quality for a clinical-stage cell therapy company, that develops T cell reprogramming technologies for patients with solid tumors.

Job Title: Quality Systems Sr. Associate, Document Management & Supplier Quality

Location: Bothell, WA 98021

Job Type: Contract

Length: 12-Months

Hours: 40 hours/week

Pay Rate: $40.00 - $49.00 per hour

Overview:

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.

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

Preferred Experience:

• Minimum of 5 years in document control experience
• Minimum of 5 years of experience working within an eQMS

Knowledge, Skills and Abilities:

• 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)

Benefits that Pride Health offers:

Pride Health offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

Apply Today! If you are interested in the position, please email your resume to rob.vanriet@pride-health.com for immediate consideration.