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Quality Assurance Senior Specialist

Thousand Oaks, CA

“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:                                                            
  • Project Management
  • Quality Management System Documentation
  • Work in Teams
  • Proficiency in Microsoft suite
  • Scrum experience preferred
  • Agile experience preferred
  • Strong organizational, communication, coordination, and meeting facilitation skills
  • Lean six sigma certification preferred

Day to Day Responsibilities:        
  • Support the global network to cascade requirements and QMS architecture to this company sites and functions
  • Manage and execute project deliverables to eliminate document redundancies, optimize document content, and ensure compliance
  • Collaborate with document owners and global process owners in the assessment of controlled documents and resulting actions
  • Authors, reviews or approves procedures, documentation and training material In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
Summary
The Quality Management System is the foundation of all that we manufacture, test, and store at this company to support our biggest mission, to serve the patients. This position will support the global Document Management process and a network of Subject Matter professionals to assure the documents generated at this company to support our Quality Management System are controlled, effective, and efficient.

Reporting to the Global Process Owner of Document Management this position sits in Corporate Quality Systems and is part of a very versatile team. This is a remote role and includes flexible working hours to support this company’s global footprint.

Key Responsibilities:

Support the global network to cascade requirements and QMS architecture to this company sites and functions
Manage and execute project deliverables to eliminate document redundancies, optimize document content, and ensure compliance
Collaborate with document owners and global process owners in the assessment of controlled documents and resulting actions
Authors, reviews or approves procedures, documentation and training material

In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

Preferred Qualifications
Degree educated with 7+ years of experience in a pharmaceutical/drug/device manufacturing environment
Well-rounded knowledge Quality Management Systems, especially Document Management
Project Management and Data Analytics
Understanding of Device / Combination Product Regulations
Strong organizational, communication, coordination, and meeting facilitation skills
Independent, self-motivated, organized, able to multi-task across a global network
Cultural awareness and dexterity
Innovation mentality with aptitude for developing ideas into measurable objectives
Experience with collaboration tools such as Teams, Smartsheets, Miro etc.

"This posting is for Contingent Worker, not an FTE"
 

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