Quality Assurance & Document Control Specialist

Xseerpharma; Los Angeles (CA); Hybrid; USD 75,000 - 110,000; Full time

Job summary

Xseerpharma in Los Angeles seeks a Quality Assurance Specialist focused on Document Control to maintain quality records and controlled documents for a 503B facility. You will support life-cycle management, investigations, change controls, and training documentation while ensuring compliance with cGMP, FDA expectations, and internal procedures.

Collaborate with Production, QC, Engineering, and Supply Chain to keep documents current, review records, and prepare for inspections.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or a related field.
• 2-4 years of experience in Quality Assurance or document control in a pharmaceutical/503B setting.
• Working knowledge of cGMP, FDA 503B guidance, USP <797>, <800>, and <85> requirements.
• Strong written and verbal communication skills with attention to detail.
• Proficiency with document-control systems and tracking tools (Qualio, MasterControl, MS Project, Excel).

Responsibilities

• Support CAPAs, deviations, investigations, and change controls within QA.
• Draft, revise, format, route, approve, issue, and retire SOPs, batch records, forms, and specs.
• Maintain document-control workflows in the electronic quality management system.
• Verify controlled documents are reviewed and approved before issuance.
• Assign document numbers, revisions, effective dates, and classifications.
• Maintain current/obsolete document versions and ensure approvals for use.
• Coordinate issuance, distribution, reconciliation, and archival of documents.
• Review documents for completeness, formatting, and compliance with good documentation practices.
• Support training documentation issuance and maintenance of training records.
• Assist with audits, inspections, and readiness activities.

Skills

Attention to detail

Written and verbal communication

Document-control practices

Education

Bachelor's degree in Life Sciences/Pharmacy/related field

Tools

Qualio

MasterControl

MS Project

Excel

Job description

Xseerpharma in Los Angeles seeks a Quality Assurance Specialist focused on Document Control to maintain quality records and controlled documents for a 503B facility. You will support life-cycle management, investigations, change controls, and training documentation while ensuring compliance with cGMP, FDA expectations, and internal procedures.

Collaborate with Production, QC, Engineering, and Supply Chain to keep documents current, review records, and prepare for inspections.