Qa specialist [h1.location_city]

Pci Pharma Services Qa Specialist Compliance

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 :

Preferred :

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.

Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer / Vet / Disabled