Quality Coordinator

ABOUT THE ROLE

The Quality Coordinator supports Adept Life Sciences' Quality Assurance function by maintaining document control systems, supporting quality assurance activities across manufacturing, and helping the department run efficiently through smart use of digital and AI-based tools. This role is essential to keeping our regulated, high-stakes manufacturing environment audit-ready, organized, and compliant, and plays a key part in upholding Adept Life Sciences' reputation for scientific integrity and operational excellence as a trusted contract manufacturing partner in the nutraceutical industry.

KEY RESPONSIBILITIES & DUTIES

Document Control

• Maintain and control controlled documents, including SOPs, batch production records (BPRs), specifications, and work instructions.
• Manage document change control, including routing, version tracking, approvals, and archival of obsolete versions.
• Ensure accurate, complete, and organized filing of quality records (electronic and/or physical) in accordance with GMP recordkeeping requirements.
• Maintain the master document list and ensure controlled copies are distributed to the correct departments.
• Support internal and external audits by quickly retrieving requested documentation and demonstrating document control compliance.

Quality Assurance Support

• Assist with review and disposition of batch records, certificates of analysis (COAs), and other quality release documentation.
• Support deviation, non-conformance, and CAPA (Corrective and Preventive Action) documentation and tracking through to closure.
• Help coordinate and prepare documentation for internal audits, customer audits, and regulatory inspections (FDA, NSF, and other third-party certifiers).
• Maintain training records and assist in tracking employee GMP and SOP training completion.
• Support supplier and vendor quality documentation, including certificates, qualification files, and approved vendor lists.
• Assist with customer complaint documentation and follow-up tracking.

AI & Digital Tools

• Comfortably use AI-based tools (e.g., Claude or similar platforms) to streamline document review, summarize records, organize data, and support administrative workflows.
• Help identify opportunities to apply AI and automation to reduce manual document handling and improve accuracy and turnaround time.
• Maintain proficiency with the company's electronic quality management system (eQMS), document control software, and standard office productivity tools.
• Support the Quality team in adopting new digital tools and processes as the department modernizes its systems.

Cross-Functional Collaboration

• Partner with Production, Warehouse, and Purchasing to ensure documentation keeps pace with production schedules and material receipts.
• Work with Customer Service and Sales to relay client documentation requests, including certificates of analysis, spec sheets, and stability data.
• Support Regulatory and Quality leadership with documentation needed for product registrations, label reviews, and regulatory filings.

General & Administrative

• Prepare quality metrics, reports, and summaries for management review.
• Maintain confidentiality of proprietary formulas, customer information, and quality records.
• Perform other duties as assigned to support the Quality department and company objectives.

WHAT SUCCESS LOOKS LIKE

Documentation & Compliance

• Controlled documents are accurate, current, and properly versioned at all times.
• Change control, deviations, and CAPAs are documented completely and closed out on schedule.
• Quality records consistently meet GMP recordkeeping standards with no findings on internal review.

Audit Readiness

• Requested documentation can be located and produced quickly during internal or external audits.
• Internal and third-party audits proceed smoothly with minimal document-related findings.
• Training records are current and demonstrate full compliance across the production team.

Efficiency & Innovation

• AI and digital tools are used proactively to reduce manual document handling and turnaround time.
• The Quality team's document workflows are well-organized, current, and easy for other departments to navigate.

QUALIFICATIONS & SKILLS

EDUCATION

• High school diploma or equivalent required; Associate's or Bachelor's degree in a related field preferred.

SKILLS REQUIRED

• 1 years of experience in a document control, quality assurance, or quality administration role, preferably within nutraceutical, dietary supplement, food, or pharmaceutical manufacturing.
• Working knowledge of GMP requirements (21 CFR Part 111 and/or Part 117) and general regulatory documentation practices.
• Strong attention to detail and comfort working within highly structured, compliance-driven processes.
• Proficiency with Microsoft Office (Word, Excel, Outlook) and general comfort learning new software platforms.
• Demonstrated comfort using AI tools in a work setting, or strong willingness and aptitude to learn.
• Excellent organizational skills with the ability to manage multiple document workflows and deadlines simultaneously.
• Strong written and verbal communication skills.
• Maintain a regular and dependable attendance record with the ability to commit to at least 40 hours weekly during normal business hours with minimal instances of unplanned absence.

PREFERRED EXPERIENCE (NOT REQUIRED)

• Experience with an electronic quality management system (eQMS) or document control software.
• Familiarity with audits from FDA, NSF, USP, or other third-party certification bodies.
• Experience supporting CAPA, deviation, or non-conformance investigations.

Pay: From $24.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $24