19 days old

Quality Assurance Specialist

La Jolla Pharmaceutical
Waltham, Massachusetts 02451
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

Position Overview  

The Associate Manager of Quality Assurance is responsible for overseeing and managing the vendor qualification program and audits for La Jolla including continuous improvement initiatives and maintenance of La Jolla’s document management system and Training Program. 

 

Responsibilities 

  • Manages the vendor qualification process, maintains the approved vendor list, and assigns and tracks vendor quality events.
  • Develops metrics related to vendor quality and La Jolla and vendor quality events.
  • Reviews and updates quality agreements to ensure compliance with internal processes and requirements.
  • Manages the external and internal audit schedule including tracking the audit report completion, the audit response from vendors and any remaining open observations.
  • Oversees the GxP training program - maintains training curriculum, schedules and facilitates the training sessions.
  • Manages the electronic document management system (Veeva – QualityDocs) as the System Administrator.
  • Reviews and facilitates document administration in Veeva to ensure the correct use of templates, correctly entered metadata, naming conventions, document types, etc.
  • Documents Veeva changes via an IT Change Control and executes scripts with evidence
  • Provides training to employees on Veeva systems.
  • Collaborates with cross-functional departments to ensure timely implementation of document change requests.
  • Organizes and ensures accurate and reliable filing systems for all paper-based quality documents on and off-site.
  • Participates in regulatory inspections as co-lead.
  • Other Quality Assurance responsibilities as assigned.

Requirements

Qualifications 

 

Education and Experience: 

  • BA or BS degree in scientific or health related discipline or equivalent experience 
  • 5+ years of experience in an FDA regulated industry 
  • Electronic Document Management System experience required 
  • Veeva experience preferred 

 

Specialized Knowledge: 

  • Strong understanding and knowledge of industry standards, concepts and current cGMP (21 CFR Parts 210 & 211 & Part 11) and other agency standards and guidelines as they relate to quality systems/quality assurance 

 

Other Skills and Abilities: 

  • Self-motivated, independent, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities 
  • Ability to interact constructively and efficiently with co-workers within and across departments and management 
  • Ability to resolve day-to-day issues efficiently while maintaining compliance 
  • Proactive approach to problem solving 
  • Clear, concise writing skills and good verbal presentation skills 
  • Proficiency in using the internet, Microsoft Word, Power Point, Excel, Adobe, and SharePoint 
  • Comply with Company quality standards/SOPs and participate in the implementation of new quality systems 
  • Provide solutions to problems. Solutions are imaginative, thorough, practical, and consistent with organization objectives
  • Solves conflict and addresses workplace issues in professional and collaborative manner 

Categories

Posted: 2021-04-22 Expires: 2021-05-22

Share this job:

Quality Assurance Specialist

La Jolla Pharmaceutical
Waltham, Massachusetts 02451

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast