Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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.
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.
ESSENTIAL DUTIES AND 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.
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.
- 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
#LI-RS1
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Skills 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 or administrative support
- Ability to perform computer tasks and knowledge of various computer programs
- Excellent communication skills, both written and verbal
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
-
Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
-
Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
-
Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
