LI
QA Specialist
LanceSoft Inc
- 🇺🇸 United States
- On-site
- 3 days ago
- Technical Writing
- Agile
- Excel
- PowerPoint
- Visio
3 days ago
Location: San Diego, CA – 92121
Duration: 3 Months
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
- An equal opportunity employer, Client welcomes and encourages diversity in our workforce.
- We provide reasonable accommodation to qualified individuals with disabilities.
QA Specialist · LanceSoft Inc