Senior Document Control Specialist

Select Source International; California; Presencial; USD 40.000 - 54.000; A tiempo parcial

Descripción de la vacante

Select Source International in San Diego, CA seeks an experienced Senior Document Control Specialist for a 2-month contract. You will coordinate change orders, manage document control and deviations, and ensure compliance with 21 CFR 820 and ISO 13485 standards.

Responsibilities include issuing document numbers, maintaining SOPs, training staff, and supporting audits. This role requires strong technical writing skills and knowledge of electronic document management systems.

Formación

• Bachelor's Degree or equivalent experience in quality/compliance.
• 2+ years in QA or document control in regulated industry.
• Knowledge of 21 CFR 820 and ISO 13485:2016.
• Experience with electronic document management systems.
• Experience with technical writing and SOPs.
• Agile DMS experience preferred.

Responsabilidades

• Serve as Change Order Coordinator for the facility.
• Manage document change orders and deviations from review to release.
• Ensure documents comply with GxP and company procedures.
• Issue document numbers and manage archiving and obsolescence.
• Provide document control training and QA-related materials.
• Support internal and external audits.
• Contribute to continuous improvement of the QMS.

Conocimientos

Quality Assurance

Document Control

Technical Writing

SOP drafting

Audit readiness

Educación

Bachelor's Degree

Equivalent combination of education and experience

Herramientas

Agile Document Management System

Descripción del empleo

Job Description

Job Title: Senior Document Control Specialist

Location: San Diego, CA 92121

Duration: 02 months of Contract (with possible extension)

Pay Rate: 34.00/hr.

Job Description

Responsibilities:

• Perform the role of Change Order Coordinator for the facility.
• Independently facilitate the Document Change Order and Deviations including formatting, coordinating the review and approval process, tracking and routing-controlled documents, and release of documents in a timely manner.
• Ensure that any new documents or changes to existing documents are appropriate, justified, accurate, complete, meets Good Documentation Practices, and approved by the required functional areas according to established procedures.
• Issue document numbers, lab notebooks numbers and part numbers.
• Assist in drafting, formatting, editing and rewriting SOPs in support of the quality systems across the organization.
• Ensure document reviews are performed periodically in a timely manner by Document Owners. Manage archiving, obsolescence and document storage.
• Perform Document Control training for new and existing employees.
• Support development of QA-related training materials.
• Assist with training assignment and collection of training metrics in Metro.
• Trend Document Control Metrics for Management Review.
• Respond to queries and issues raised by Document Owners and Approvers in a timely manner.
• Assist with internal and external audits.
• Support the continuous improvement to the Quality Management System, with a specialty focus on document control and change order processes.

Basic qualifications | education:

• Bachelor's Degree and/or an equivalent combination of education and experience.
• 2 years or more of experience in Quality Assurance or in Document Control, in a laboratory, medical device or similarly regulated industry.
• Working Knowledge of 21CFR820, ISO 13485:2016 standard.
• Experience processing changes using an electronic documentation system.
• Experience with technical writing, formatting and trending of data.
• Agile Document Management System experience preferred.

Company Description

Select Source International (SSI) is a distinguished workforce solutions provider with nearly 25 years of experience delivering top-tier staffing, recruiting, and managed services. Based in Minneapolis, Minnesota, SSI has established itself as a global leader, serving a broad, diverse clientele across industries with unwavering dedication and excellence.

As a trusted partner, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your evolving workforce needs. SSI is ISO 9001, ISO 14001, and SOC 2 Type II certified, underscoring our strict commitment to quality, environmental responsibility, and data security. Our industry-leading capabilities are further validated by numerous awards in sustainability and supplier diversity.