QA Specialist I - 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:

• •​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

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• 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.