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QA Specialist I - Compliance

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PCI Pharma Services

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Location:
United States , Bedford

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Reporting to the Director of Quality Systems & Compliance, the QA Specialist – Compliance is responsible for providing essential administrative support to the Compliance team and managing various client and internal audit documentation.

Job Responsibility:

  • Provide comprehensive administrative support to the Director of Quality Systems & Compliance and the Compliance team
  • Coordinate all client and internal audits by securing conference rooms, scheduling meetings, obtaining and organizing documents, and ensuring a professional and welcoming environment
  • Order and maintain office supplies for the Compliance team, as needed
  • Manage the Compliance spreadsheets for tracking of all client and internal audit schedules
  • Manage the Compliance spreadsheets for tracking of all client and internal audit responses
  • Responsible for managing the transfer of client audit report observations to the PCI audit response templates
  • Provides support as directed by the Director of Quality Systems & Compliance and the Compliance team during FDA and other regulatory agency inspections
  • Provide continuous improvement support as directed by the Director of Quality Systems & Compliance and the Compliance team
  • Assist in follow up and tracking of client and internal audit commitments to assure timely closure as directed
  • Scan, store, and maintain documentation in electronic and physical filing systems, if applicable, ensuring accuracy, completeness and accessibility
  • Assist with other duties as assigned

Requirements:

  • Associates degree plus 5 years of relevant experience or HS diploma and 10 years relevant experience
  • Minimum of 5 years of experience in office coordination, administrative support, or documentation management, preferably in a regulated industry such as pharmaceuticals or biotechnology
  • Intermediate ability to perform computer tasks and knowledge of various computer programs
  • Excellent communication skills, both written and verbal, with the ability to interact professionally with internal and external stakeholders at all levels
  • Ability to follow instructions and respond to management direction
  • Ability to work independently and/or as part of a team
  • Ability to display excellent time management skills
  • Ability to work in a dynamic, paced work environment
  • Ability to communicate clearly and concisely with cross functional staff, members of management and external clients
  • This position may require additional hours and/or weekend work

Nice to have:

  • Exceptional organizational skills and attention to detail
  • Ability to make risk based decisions and resolve issues with minimal guidance
  • Excellent interpersonal skills and the ability to communicate well orally and in writing
  • Proficiency in MS Office including Word, Excel, Access and Visio
  • Excellent verbal and written communication skills required
  • Ability to work in a dynamic, fast paced work environment
  • Honesty, integrity, respect and courtesy with all colleagues
  • Creative with the ability to work with minimal supervision and balanced with independent thinking
  • Resilient through operational and organizational change

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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