QA Specialist

Lancesoft; San Diego (CA); On-site; USD 55,000 - 83,000; Full time

Job summary

Lancesoft is seeking a QA Specialist / Senior Document Control Specialist in San Diego, CA for a 3-month contract. The role focuses on change orders, document control, and maintaining compliance with Good Documentation Practices within a regulated environment.

You will coordinate changes, issue numbers, draft SOPs, train staff, and support audits to improve the Quality Management System. Strong knowledge of 21 CFR 820 and ISO 13485 is required.

Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• 2+ years in QA or Document Control in a regulated environment.
• Working knowledge of 21 CFR 820 and ISO 13485:2016.
• Experience with electronic document management systems.
• Experience with technical writing, formatting, and data trending.
• Agile Document Management System experience preferred.

Responsibilities

• Coordinate Change Order processes and document deviations.
• Format, review, approve, track, and release controlled documents.
• Ensure documents meet Good Documentation Practices and procedures.
• Issue document, lab notebook, and part numbers.
• Draft, format, edit, and rewrite SOPs for QA systems.
• Train in Document Control for staff and new hires.
• Manage archiving, obsolescence, and storage of documents.
• Support QA training materials and metrics.
• Assist audits and continuous improvement of the QMS, focusing on document control and change orders.

Skills

Quality Assurance

Document Control

Technical Writing

Agile DMS

Education

Bachelor's Degree or equivalent

Job description

Title & Location

QA Specialist / Senior Document Control Specialist

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.