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Occupational Medicine Clinical Staff Coordinator - SRS Kearny Mesa - Full-Time - Day Shift SHARP HEALTHCARE
San Diego, CA1 day ago
- $80,000–$96,000 Per Year
Highlights
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. Correspond with regulatory agencies and individuals by phone, email or fax as appropriate to follow-up on issues as requested.
Numbers & Facts
| Location | CA |
| Industry | Biotechnology/Pharmaceuticals |
| Company Size | 500 to 999 employees |
| Year Founded | 1976 |
| Website | http://scantibodies.com/ |
Description
Position title
Quality Assurance Admin Assistant
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
- Associates 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 drivers 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
- Researches regulations and standards for new and existing products to develop regulatory strategies
- Compiles regulatory submissions such as 510(k) filings, PMA, etc.
- Reviews CE Marking Technical Files to determine gaps and any necessary ongoing activities to maintain compliance to current regulations and standards
- Reviews Design History Files to determine gaps and any necessary ongoing activities to maintain compliance to 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- Identify and revise outdated established procedures and assist with revisions of established procedures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 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
Job Benefits
We offer a comprehensive benefits package to include paid sick, vacation, medical, dental, vision, life insurance and 401(k).
Contacts
Email your resume to: hr@scantibodies.com
Scantibodies Laboratory, Inc. is located at:
10946 Woodside Avenue North, Santee, CA 92071
About Company
This is a story of one man’s dreams. At the age of 19 Tom married and had to drop out of college. He moved to San Diego in 1970 where his wife worked as a secretary and Tom got into San Diego City College. Tom worked to get into UCSD to earn his Bachelor’s degree. In order to support his family after his first son was born, Tom worked as a research technician at Mercy hospital and a Lab Manager at the VA hospital. He discovered that there were no commercial suppliers of antibodies. Tom decided to measure what to date had not been measured – hormones with the use of antibodies. If he could make a go of his business of making goat antibodies , he would work to fulfill his original goal of helping people.