Senior Document Control Specialist

Experis; San Diego (CA); On-site; USD 39,000 - 44,000; Full time

Job summary

Experis is seeking a QA Specialist/Documentation Specialist to join our Fortune 500 client in San Diego, onsite. The role focuses on document control, change orders, SOP drafting and training support within a regulated environment.

Qualifications include a Bachelor's degree and 2+ years in QA or Document Control, with knowledge of 21CFR820 and ISO 13485:2016. Proficiency in Microsoft Office, Visio, and electronic document systems is expected.

Qualifications

• Bachelor's Degree or equivalent combination of education and experience.
• 2+ years of experience in Quality Assurance or Document Control in regulated environments.
• Familiarity with 21CFR820 and ISO 13485:2016 is preferred.

Responsibilities

• Coordinate Change Order processes for the facility and ensure timely review and approval.
• Format, track, and release controlled documents and related deviations.
• Ensure new or updated documents meet Good Documentation Practices and are properly approved.

Skills

Quality Assurance

Documentation

SOPs

Document Control

Regulatory Knowledge

Education

Bachelor's Degree

Tools

Microsoft Office

Visio

Electronic document control system

Job description

$28.0 - $32.0/hourly Posted 1 Day Ago Less than 10 Applies

Experis

Title: QA Specialist/Documentation Specialist
Location: San Diego, California(100% Onsite)
Duration: 3+ Months (Possibility to extend)
Shift Time: 8am to 5pm
Pay Range: $28/hr to $32/hr (On W2)

We are looking for a QA Specialist/Documentation Specialist to join one of our Fortune 500 clients.

Job 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.

Qualifications:

• 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.

We are looking for the candidate who are eligible to work with any employers without sponsorship.

$28.0 - $32.0/hourly Posted 1 Day Ago Less than 10 Applies