QA Specialist I - Compliance

Essential Duties And Responsibilities

• Provide comprehensive administrative support to the Director of Quality Systems & Compliance and the Compliance team.
• Cook up 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.
• Provide 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.
• Aid in following up and tracking of client and internal audit commitments to assure timely closure as directed.

Qualifications

• Required: 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.

Preferred

• Exceptional organizational skills and attention to detail.
• 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.
• The 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.

About the Role

We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.