Senior Document Control Specialist

Abbott; San Diego (CA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical plan

Dental plan

Vision plan

401(k)

Job summary

Abbott in San Diego, CA seeks a Senior Document Control Specialist to manage change orders, document control, and QA documentation in a regulated environment. You will ensure proper approvals, issue identifiers, and support SOP development and audits.

Responsibilities include training, metric collection, and continuous improvement of the Quality Management System, with emphasis on good documentation practices and cross-functional collaboration.

Qualifications

• Bachelor's degree and/or equivalent combination of education and experience.
• 2+ years in Quality Assurance or Document Control in regulated industry.
• Working knowledge of 21 CFR 820 and ISO 13485:2016.
• Experience with electronic documentation systems and document control processes.
• Experience with technical writing and data trending.

Responsibilities

• Perform the role of Change Order Coordinator for the facility.
• Coordinate document change orders and deviations, review and approval, track and release controlled documents.
• Ensure documents meet GxP and procedural requirements and get proper approvals.
• Issue document numbers, lab notebooks numbers, and part numbers.
• Assist in drafting, formatting, editing and rewriting SOPs for quality systems.
• Manage document reviews, archiving, obsolescence and storage.
• Provide Document Control training and support QA training materials.
• Collect training metrics and support audits.
• Trend Document Control Metrics for Management Review.
• Respond to queries from Document Owners and Approvers timely.
• Support continuous improvement of the Quality Management System.

Skills

Detail-oriented

Independent worker

Communication skills

English proficiency

Education

Bachelor's Degree or equivalent

2+ years QA/Document Control experience

Knowledge of 21 CFR 820 / ISO 13485

Tools

Electronic documentation system

QMS tools

Visio

Job description

Title: Senior Document Control Specialist

Location: San Diego, CA

Duration: 1 Months

1005 Onsite

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.

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

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.