Senior Document Control Specialist

Job Description

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.

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.

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.\r\n\r\nAs 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.