Highlights
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. 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.
Numbers & Facts
| Location | San Diego, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $30 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Title:QA Specialist II
Location:San Diego, CA 92121
Duration: 01 Month (09/21/2026 to 10/20/2026)
Responsibilities:
Basic Qualifications | Education:
Competencies:
Location:San Diego, CA 92121
Duration: 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.
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.
Competencies:
- 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
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
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