Quality Systems Document Control Specialist

About the Role

We are looking for a Quality Systems Document Control Specialist to join our Quality Unit in XeCare Pharmacy. This role is responsible for supporting the document control system and lifecycle of controlled documents in a compounding pharmacy operating under 503A regulations. With a strong emphasis on Change Control support, SOP development, controlled issuance, review, filing, archival, and compliance tracking, the Document Control Specialist ensures that all documentation meets regulatory requirements and supports operational excellence.

You Will

• Support the administration of the Document Control System, ensuring proper management of controlled documents such as SOPs, batch records, logbooks, forms, policies, and protocols.
• Support the site level implementation of change controls and the impact to site documentation and defined processes.
• Support the design and enhancement of quality system tools and workflows, ensuring alignment with regulatory requirements and business needs.
• Issue and track SOPs and other controlled documents, ensuring only current, approved versions are in circulation.
• Assist in drafting, editing, and formatting SOPs, work instructions, and policies, ensuring clarity, consistency, and alignment with USP <795>, <797>, <800>, and FDA 21 CFR 210/211.
• Support SOP lifecycle management, including periodic review, approval workflows, revision history tracking, and retirement of obsolete versions.
• Support cross-functional SME reviews of SOPs and controlled documents, ensuring input from QA, Production, QC, and Compliance.
• Ensure timely training roll-out when new or revised SOPs are released, and maintain records to demonstrate compliance in alignment with the Training department and Operations teams.
• Maintain both electronic and physical filing systems, ensuring secure storage, easy retrieval, and audit readiness.
• Monitor document-related deviations, including missing signatures, uncontrolled copies, or outdated references, and escalate to QA Management for corrective action.
• Prepare and provide documentation packages for regulatory inspections and customer audits.
• Partner with QS Management to support continuous improvement of the document control process, including digitization initiatives and standardization projects.

You Have

• Bachelor’s degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience.
• 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
• Hands-on experience with SOP drafting, formatting, and controlled documentation systems.
• In-depth knowledge of cGMP documentation practices, USP standards, and FDA record-keeping requirements.
• Exceptional attention to detail with strong editing, writing, and organizational skills.
• Familiarity with electronic document management systems (EDMS) or validated document control or quality management software.
• Strong collaboration skills, with the ability to work across QA, Production, and Compliance teams.

Benefits

Our Benefits (There Are More but Here Are Some Highlights):

• Comprehensive health benefits including medical, dental & vision, and parental leave
• 401k benefits with employer matching contribution

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match.

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