Senior Document Control Specialist (QA Specialist)

Generis TEK Inc.; San Diego (CA); On-site; USD 36,000 - 52,000; Full time

Job summary

Generis TEK Inc. in San Diego, CA is recruiting a Senior Document Control Specialist (QA Specialist) for a 3-month contract onsite. The role focuses on maintaining the Document Control Management System, supporting quality metrics and QA activities to uphold the QMS.

The successful candidate will manage change orders, ensure documents meet regulatory requirements, and coordinate cross-functional reviews. Strong writing, formatting, and documentation skills are essential.

Qualifications

• Bachelor’s Degree or an equivalent combination of education and experience.
• 2+ years of experience in Quality Assurance or Document Control in a regulated lab/medical device setting.
• Working knowledge of 21 CFR 820 and ISO 13485:2016.
• Experience with electronic document management systems.
• Experience with technical writing, formatting, and data trending.
• Experience with Agile Document Management System.

Responsibilities

• Act as Change Order Coordinator for the facility.
• Coordinate document change orders and deviations; manage reviews and approvals.
• Ensure new or revised documents meet regulatory requirements and are approved by relevant functions.
• Issue document, lab notebook, and part numbers.
• Assist in drafting and editing SOPs for the Quality Management System.
• Manage archiving, obsolescence and storage of controlled documents.
• Provide Document Control training and contribute to QA training materials.
• Support QA metrics trending and management review.
• Assist with internal and external audits.
• Support continuous improvement of the QMS, focusing on document control and change order processes.

Skills

Document control

Quality assurance

Metrics trending

Education

Bachelor’s degree or equivalent

Tools

MS Office

Job description

Position Details

We have Contract role Senior Document Control Specialist (QA Specialist) for client at San Diego, CA. Please let me know if you or any of your friends would be interested in this position.

Senior Document Control Specialist (QA Specialist)- San Diego, CA

Location : San Diego, CA — 92121 (Onsite)

Project Duration : 3 Months

Shift Timing : 9:00 AM to 5:30 PM (Mon to Fri)

Pay Rate : $32.00 per hour on W2

Job Description

This Document Control Specialist opportunity is available with Infectious Disease Developed Markets (IDDM) Business unit within Client, at the location in Towne Centre San Diego, CA. Document Control Specialist who will effectively execute and maintain compliant Document Control Management System. In addition, this role will also trend quality metrics and perform other quality related activities to support the Quality Management System.

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 required.

Competencies

• Proficient with MS Office, including Word, Excel, PowerPoint, electronic document control tools and Visio.
• Ability to understand QMS procedures and ability to 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

Top 3 Skills

• Document Control Management
• Quality Assurance Experience
• Metrics trending

Interview Process

• Phone followed by In-Person interview.