Quality Assurance Documentation Coordinator

Position Summary SMSbiotech, Inc is seeking a detail-oriented Quality Assurance Documentation Coordinator to support the day-to-day operations of our Quality Management System (QMS). This role is ideal for an organized, process-driven professional who thrives on keeping systems running smoothly. No prior biology or scientific background is required. The successful candidate will be trained on our cGMP environment and will focus on documentation control, compliance tracking, internal audit coordination, training management, and procurement support. Key Responsibilities QMS Documentation Management Maintain, organize, and archive all QMS-controlled documents, including SOPs, work instructions, forms, logbooks, and records. Ensure documents are reviewed, approved, and distributed according to document control procedures. Track document revision history and manage version control across the QMS library. Route documents for electronic or wet-ink signatures and ensure timely completion of approval cycles. Logs, Forms & Compliance Tracking Monitor that all production logs, batch records, equipment logs, cleaning logs, and environmental monitoring forms are completed accurately and submitted on time. Flag overdue or incomplete records and follow up with responsible personnel to ensure timely closure. Support deviation, CAPA, and change control documentation by ensuring forms are initiated, routed, and closed within established timelines. Internal Audit Coordination Assist in planning and scheduling the annual internal audit program in accordance with QMS-009 (Internal Quality Audits) or equivalent SOP. Coordinate audit logistics including scheduling auditors, preparing audit checklists, and distributing audit notifications. Track audit findings, observations, and corrective actions to closure. Maintain audit records and compile audit summary reports for management review. Training Management Maintain the training matrix and ensure all personnel complete required training on new and revised SOPs within defined timelines. Track training completion status, send reminders for upcoming or overdue training, and escalate non-compliance. Coordinate new-hire onboarding training schedules in collaboration with department leads. File and organize training records (certificates, sign-off sheets, read-and-understand forms). Ordering & Procurement Support Assist with ordering laboratory and facility supplies, consumables, and QA-related materials. Track purchase orders, confirm deliveries, and maintain procurement logs. Coordinate with vendors and suppliers to obtain quotes, certificates of analysis (CoAs), and other required documentation. Support qualified supplier list maintenance and vendor qualification recordkeeping. Qualifications Required High school diploma or equivalent; associate or bachelor's degree preferred (any field). Minimum 1-2 years of experience in document control, administrative coordination, quality assurance support, or a similar role (pharmaceutical, manufacturing, or regulated industry preferred). Strong organizational skills with exceptional attention to detail. Proficiency in Microsoft Office Suite (Word, Excel, Outlook) and document management systems. Ability to manage multiple priorities and meet deadlines consistently. Excellent written and verbal communication skills. Preferred Familiarity with c

GMP, FDA

regulations, or ISO quality standards (training will be provided). Experience with electronic quality management systems (eQMS) or document control software. Prior experience coordinating audits or managing training records. Basic understanding of procurement and supply chain processes. Working Conditions Office-based role within the SMSbiotech, Inc biomanufacturing facility with occasional access to controlled manufacturing areas (gowning training provided). Standard business hours with occasional flexibility needed during audits, inspections, or regulatory submissions. Must be able to work on-site; this is not a remote position. What We Offer Comprehensive on-the-job training in cGMP documentation practices — no science background needed. Opportunity to grow within a fast-paced biotech startup environment. Exposure to the full quality system lifecycle in a biomanufacturing setting. Collaborative team culture with direct mentorship from experienced quality professionals.

Pay:

$52,000.00 - $68,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Vision insurance

Education:

Associate (Required)

Language:

English (Required)

Location:

San Diego, CA 92121 (Preferred) Ability to

Commute:

San Diego, CA 92121 (Required)

Work Location:

In person