Senior QA Technician - Document Control

Xseer Pharma; Los Angeles (CA); On-site; USD 80,000 - 105,000; Full time

Job summary

Xseer Pharma is seeking a Senior Document Control Specialist to independently manage daily document-control activities at its cGMP production facility. You will maintain controlled documents through their lifecycle, ensure accuracy, traceability, and accessibility, and support audits.

You will train staff, improve processes, and collaborate with Quality, Operations, HR to align documentation priorities with production schedules.

Qualifications

• Hands-on experience managing controlled documents within a cGMP environment.
• Good Documentation Practices, revision control, approval workflows, and data integrity.
• Proficiency in Microsoft Word, Excel, Outlook, and electronic document-management systems.
• Strong proofreading, organizational, problem-solving, and written and verbal communication skills.
• Ability to manage competing priorities and elevate matters requiring management decisions.

Responsibilities

• Independently manage assigned document-control workflows, systems, logs, and records.
• Coordinate preparation, formatting, review, and revision of SOPs, forms, manuals, batch-record templates, protocols, reports, and other controlled documents.
• Review documents for completion, formatting consistency, correct references, revision history, and adherence to Good Documentation Practices.
• Assign and verify document numbers, revision numbers, effective dates, classifications, and periodic review dates.
• Route documents to authorized reviewers and approvers, track outstanding actions, and escalate overdue reviews or unresolved issues.
• Issue and distribute approved controlled documents, reconcile controlled copies, and ensure obsolete versions are removed from use.
• Maintain master document lists, revision histories, distribution records, and secure physical and electronic archives.
• Coordinate periodic document reviews with document owners and follow up to ensure timely completion.
• Coordinate document-related change-control activities, including tracking affected documents, required approvals, and associated training documentation.
• Maintain records according to approved retention schedules and coordinate authorized disposition when required.
• Perform periodic checks of document-control records and practices, identify discrepancies, and coordinate corrections with responsible departments.
• Coordinate document retrieval during internal audits, customer audits, and regulatory inspections; maintain request logs and track documentation follow-up.
• Train employees and provide guidance to junior staff on document-control procedures, templates, systems, and documentation practices.
• Track document-control workload, overdue reviews, and recurring errors; report concerns and improvement opportunities to management.
• Collaborate with Quality, Operations, HR, and other departments to coordinate documentation priorities and support production schedules.
• Protect the confidentiality, security, and integrity of company documents and records.

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Electronic document-management systems

Job description

The Senior Document Control Specialist independently manages daily document-control activities supporting the organization’s cGMP production facility. This position maintains physical and electronic controlled documents throughout their lifecycle, including preparation, revision, review routing, issuance, distribution, archival, and retention.

The role ensures documentation is accurate, current, traceable, and accessible in accordance with company procedures and applicable requirements. The Senior Document Control Specialist also provides guidance to employees, resolves documentation issues, supports audits and inspections, and improves document-control processes.

Job Activities and Responsibilities

• Independently manage assigned document-control workflows, systems, logs, and records.
• Coordinate the preparation, formatting, review, and revision of SOPs, forms, manuals, batch-record templates, protocols, reports, and other controlled documents.
• Review documents for completion, formatting consistency, correct references, revision history, and adherence to Good Documentation Practices.
• Assign and verify document numbers, revision numbers, effective dates, classifications, and periodic review dates.
• Route documents to authorized reviewers and approvers, track outstanding actions, and **escalate** overdue reviews or unresolved issues.
• Issue and distribute approved controlled documents, reconcile controlled copies, and ensure obsolete versions are removed from use.
• Maintain master document lists, revision histories, distribution records, and secure physical and electronic archives.
• Coordinate periodic document reviews with document owners and follow up to ensure timely completion.
• Coordinate document-related change-control activities, including tracking affected documents, required approvals, and associated training documentation.
• Maintain records according to approved retention schedules and coordinate authorized disposition when required.
• Perform periodic checks of document-control records and practices, identify discrepancies, and coordinate corrections with responsible departments.
• Coordinate document retrieval during internal audits, customer audits, and regulatory inspections; maintain request logs and track documentation follow-up.
• Train employees and provide guidance to junior staff on document-control procedures, templates, systems, and documentation practices.
• Track document-control workload, overdue reviews, and recurring errors; report concerns and improvement opportunities to management.
• Collaborate with Quality, Operations, HR, and other departments to coordinate documentation priorities and support production schedules.
• Protect the confidentiality, security, and integrity of company documents and records.

Required Qualifications

• At least 3 years of progressively responsible document-control or quality-documentation experience in a regulated manufacturing environment; 5 or more years preferred.
• Hands-on experience managing controlled documents within a cGMP environment.
• Working knowledge of Good Documentation Practices, document revision control, approval workflows, record retention, and data integrity.
• Proficiency in Microsoft Word, Excel, Outlook, and electronic document-management systems.
• Strong proofreading, organizational, problem-solving, and written and verbal communication skills.
• Ability to manage competing priorities, resolve routine documentation issues independently, and **elevate** matters requiring management decisions.

Preferred Qualifications

• Pharmaceutical, biotechnology, or sterile-manufacturing experience.
• Experience supporting audits or regulatory inspections.
• Experience training employees or mentoring junior document-control staff.
• Experience improving document workflows, templates, or tracking systems.

Physical Requirements

• Good hand-eye coordination.
• Ability to sit for extended periods and intermittently stand or move to retrieve and organize records.
• Ability to occasionally lift and move materials weighing up to 30 lbs.

Reports To

Quality Assurance Manager/Director of Operations or designated supervisor.

Appearance

Must wear clean scrubs while in the facility.