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.
\nCompany 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.
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.