Senior Document Control Specialist

Location: San Diego, California (100% Onsite)
Duration: 3+ Months (Possibility to extend)
Shift Time: 8am to 5pm
Pay Range: $28/hr to $32/hr (On W2)

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, meet Good Documentation Practices, and are approved by the required functional areas according to established procedures.
• Issue document numbers, lab notebook 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.

Requirements

• 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.

Skills

• Proficient with Microsoft Office, including Word, Excel, PowerPoint, electronic document control tools, and Visio.
• Ability to understand QMS procedures and recognize deviations from approved documented procedures.
• Self-starting, detail-oriented, and ability to focus on task at hand.
• Ability to work independently with multiple departments to resolve Document Control issues.
• Must be able to work effectively in a fast-paced, team-oriented environment.
• Well-developed English written and verbal communication skills.

Pay

$28/hr to $32/hr (On W2)

Schedule

8am to 5pm