QA & Document Control Specialist: Change Order Lead

Lancesoft; San Diego (CA); Vor Ort; USD 55.000 - 83.000; Vollzeit

Zusammenfassung

Lancesoft is seeking a QA Specialist / Senior Document Control Specialist in San Diego, CA for a 3-month contract. The role focuses on change orders, document control, and maintaining compliance with Good Documentation Practices within a regulated environment.

You will coordinate changes, issue numbers, draft SOPs, train staff, and support audits to improve the Quality Management System. Strong knowledge of 21 CFR 820 and ISO 13485 is required.

Qualifikationen

• Bachelor's degree or equivalent combination of education and experience.
• 2+ years in QA or Document Control in a regulated environment.
• Working knowledge of 21 CFR 820 and ISO 13485:2016.
• Experience with electronic document management systems.
• Experience with technical writing, formatting, and data trending.
• Agile Document Management System experience preferred.

Aufgaben

• Coordinate Change Order processes and document deviations.
• Format, review, approve, track, and release controlled documents.
• Ensure documents meet Good Documentation Practices and procedures.
• Issue document, lab notebook, and part numbers.
• Draft, format, edit, and rewrite SOPs for QA systems.
• Train in Document Control for staff and new hires.
• Manage archiving, obsolescence, and storage of documents.
• Support QA training materials and metrics.
• Assist audits and continuous improvement of the QMS, focusing on document control and change orders.

Kenntnisse

Quality Assurance

Document Control

Technical Writing

Agile DMS

Ausbildung

Bachelor's Degree or equivalent

Jobbeschreibung

Lancesoft is seeking a QA Specialist / Senior Document Control Specialist in San Diego, CA for a 3-month contract. The role focuses on change orders, document control, and maintaining compliance with Good Documentation Practices within a regulated environment.

You will coordinate changes, issue numbers, draft SOPs, train staff, and support audits to improve the Quality Management System. Strong knowledge of 21 CFR 820 and ISO 13485 is required.