QA Specialist II
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Overview
Remote
On-site
Compensation
$30-$33/hour
Job Description
Title:QA Specialist IILocation:San Diego, CA 92121Duration: 01 Month (09/21/2026 to 10/20/2026)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.
- 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.
- Proficient with Microsoft 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
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FAQs About QA Specialist II Jobs at LanceSoft Inc
What is the work location for this position at LanceSoft Inc?
This job at LanceSoft Inc is located in San Diego, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at LanceSoft Inc?
Candidates can expect a pay range of $30–$33.33 per hour for this role.
What employment applies to this position at LanceSoft Inc?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at LanceSoft Inc?
You can apply for this role at LanceSoft Inc either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.