PCI Pharma Services · 1 week ago
QA Specialist I - Compliance
Bedford, NH, USA
Full-time
Onsite
Mid, Senior Level
5+ years expPCI Pharma Services is a company focused on providing life-changing therapies and has a global impact. The QA Specialist – Compliance is responsible for providing essential administrative support to the Compliance team and managing various client and internal audit documentation.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
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
Qualification
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
This position may require additional hours and/or weekend work
Preferred
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
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase