Quality Assurance Admin Assistant

Scantibodies Laboratory; Santee (CA); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Paid sick leave

Paid vacation

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k)

Job summary

Scantibodies Laboratory in Santee, California is seeking an administrative support role under the direction of the QA/QC Manager. Responsibilities include maintaining regulatory registrations, compiling submissions, and acting as project manager for QA and RA plans.

The ideal candidate should have an associate's degree, be bilingual in English and Spanish, and possess strong organizational skills. A comprehensive benefits package is offered.

Responsibilities

• Create and maintain facility registrations and regulatory documents.
• Maintain log of regulatory licenses with renewal dates.
• Research regulations and develop regulatory strategies.
• Compile regulatory submissions like 510(k) filings.
• Review CE Marking Technical Files and Design History Files.
• Identify and revise outdated established procedures.
• Correspond with regulatory agencies about issues.
• Prepare monthly books for QMR.
• Create project plans for QA and RA.
• Host facility regulatory inspections.
• Plan fire drills and conduct practical simulations.
• Act as HIPAA Privacy Officer.
• Ensure compliance with blood product lookback requirements.

Skills

Bilingual in English and Spanish

Good organizational skills

Manual dexterity

Understanding of medical terminology

Accurate data entry skills

Good verbal and written communication skills

Working knowledge of Outlook, Word, Excel and Visio

Valid driver’s license

Education

Associate’s degree or equivalent

Job description

Under the direction of the QA/QC Manager, responsible for administrative support and ensuring that SLI obtains all necessary regulatory approvals and continues to maintain these approvals.

Requirements

• Associate’s degree or equivalent
• Bilingual in English and Spanish
• Good organizational skills and manual dexterity
• Understanding of medical terminology
• Accurate data entry skills
• Good verbal and written communication skills
• Working knowledge of Outlook, Word, Excel and Visio
• Valid driver’s license, current proof of insurance, and clean driving record

Responsibilities

• Create and maintain facility registrations and any other licenses or required regulatory documents.
• Maintain a log of all regulatory licenses with appropriate renewal dates.
• Research regulations and standards for new and existing products to develop regulatory strategies.
• Compile regulatory submissions such as 510(k) filings, PMA, etc.
• Review CE Marking Technical Files to determine gaps and any necessary ongoing activities to maintain compliance with current regulations and standards.
• Review Design History Files to determine gaps and any necessary ongoing activities to maintain compliance with current regulations and standards.
• Identify and revise outdated established procedures and assist with revisions of established procedures.
• Correspond with regulatory agencies and individuals by phone, email or fax as appropriate to follow up on issues as requested.
• Prepare monthly books for QMR.
• Create project plans and act as project manager to implement plans in QA and RA.
• Host facility regulatory inspections and follow-up action results.
• Internet research as requested for regulatory issues.
• Plan fire drills and conduct practical simulations.
• Act as HIPAA Privacy Officer.
• Follow up on action items to comply with the Safety Management System.
• Ensure compliance with blood product lookback requirements.
• Maintain a clean and organized work environment.
• Regular, reliable and predictable attendance.
• May perform other job related duties as assigned.
• May be assigned to any Scantibodies location for any period of time.

We offer a comprehensive benefits package to include paid sick, vacation, medical, dental, vision, life insurance and 401(k).