Quality Assurance coordinator

Location: Boston Cleanrooms On Demand
Department: Azzur Cleanrooms On Demand Burlington LLC

Job Description

Azzur Clean Room on Demand is looking for Site Quality Liason; under general supervision, this person will report to the Site Quality Manager and executes tasks by the Azzur Cleanrooms on Demand (ACoD) quality management system.  Act as the Quality point of contact (POC) for client relations to include management of Quality to Quality meetings, crossfunctional team management, handling of documentation requests, and quality-related client notifications. Work in partnership with the Client Operations group to maintain client relations through communication and management of information flow between ACoD Quality and client personnel. 

Job responsibilities:

Responsible for maintaining the following Primary Tasks:

  1. Cross-functional team management
  2. Generation of Client material specifications working with the clients and operations to generate or update specs as needed
  3. The primary point of contact for quality-related client requests for investigations and other documentation support
  4. Provide Quality notifications to appropriate client staff within the timeframes of applicable SOPs and/or Quality Agreements, including receipt of client acknowledgment and/or approval
  5. Manage and coordinate Quality to Quality meetings, including maintenance of meeting minute records and identifying SME needs
  6. Managing client quality requests such as working with vendors as appropriate for Environmental monitoring scheduling, obtaining client-specific documentation, and ensuring they are provided promptly, including client-specific quality records, offboarding, and routine or non-routine client requests
  7. Assist client operations with quality-related onboarding of new clients.
  8. Maintain client quality notifications tracker, ensuring all notifications are tracked for quality record purposes and performed following SOPs and agreed upon timeframes.

Responsible for maintaining the following Secondary Tasks:

  1. Coordinate client training requests with client ops and quality team for new client staff and removal of client staff from badge access with other quality teams to aid in ensuring training compliance
  1. Support Client and regulatory audits as part of the site Quality team
  2. Assist with scheduling and fulfilling client training needs such as gowning or other on the job or instructor-led activities as needed
  3. Attend client meetings as designated to fulfill quality presence
  4. Support regulatory audits as needed
  5. Escalate issues as they arise from operations or Quality notifications.

Required Education:

  • Bachelor’s degree or higher in a scientific discipline, or equivalent experience

Required Work Experience: 

  • 2+ years experience in a Quality role
  • GMP experience
  • Cleanroom experience

 Preferred experience:

  • 4+ yrs experience in a Quality position
  • Previous experience interacting with clients

 

Required Knowledge:

  • Microsoft Office
  • Basic GMP and GDP

 

Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:

  • Computer skills, basic mathematical skills, use of spreadsheets, clear penmanship. Adobe Pro, Visio, Google suite

Benefits

Fulltime Employment with Azzur can offer you:

  • Flexible PTO
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays
  • Company provided laptop

Who we are:

Azzur Group is dedicated to providing clients with efficient, innovative quality, and compliance solutions from Discovery to Delivery™. With over 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.

Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.



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