Quality Systems Senior Associate, Document Management and Supplier Quality

Duties

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
  
  

Skills

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
  
  

Education

• 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
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.