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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. We're looking for a Document Control Specialist to join our Quality Assurance team. In this role, you'll be at the heart of our compliance and documentation process-helping us maintain the highest standards of safety, accuracy, and efficiency in a cGMP-regulated environment. This is a great opportunity for someone who thrives in a collaborative setting, enjoys balancing structure with problem-solving, and wants to make an impact on products that ultimately reach patients worldwide. What You'll Do As a key member of our QA team, you will:
Manage and maintain controlled documents, procedures, and records in compliance with cGMP requirements. Support document lifecycle management: review, approve, issue, distribute, archive, and obsolete records. Facilitate client batch record creation, modifications, and approvals. Maintain databases, numbering logs, and satellite areas for paper-based record systems. Issue and archive batch records, testing sheets, lab/room/equipment logbooks, and QA event documentation. Assist with audits, SOP reviews, and preparation of documentation for inspections. Draft and edit SOPs, ensuring clarity and compliance. Provide backup support for line clearances and other QA functions. Partner with colleagues across departments to deliver training and contribute to a culture of quality.
What We're Looking For
Education/Experience:
High School Diploma/Associate's degree with 8+ years of cGMP experience, or Bachelor's degree with 1-5 years of prior GMP experience (pharmaceutical industry strongly preferred). Strong organizational skills with keen attention to detail. Experience with data processing, spreadsheets, and document management systems. Proficiency in MS Office Suite. Clear and professional communication skills (written and verbal). Ability to manage multiple priorities in a dynamic environment. Team player who thrives on collaboration and continuous improvement.
Physical & Work Environment
Ability to lift up to 20 lbs., bend, squat, climb, and reach as needed. Comfortable presenting or training in group settings. Work performed in a professional manufacturing/office environment.
Why Join Us?
Be part of a mission-driven company ensuring quality and compliance for life-saving products. Collaborate with a highly skilled team in a supportive, growth-oriented environment. Gain exposure to a wide range of quality processes and contribute to continuous improvement initiatives.
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.
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PCI Pharma Services
Sep 02, 2025